MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-14 for GIGLI SAW 50 CM 962072000 manufactured by Depuy International Ltd. 8010379.
[138800212]
Product complaint # (b)(4). Investigation summary: the reported event has been evaluated and will be monitored. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. A complaint was received regarding gigli saws stating: "we had a problem with 3 different gigli saws on friday afternoon. "an additional information request found: "the saw is used by mr. (b)(6) a for his hip procedures, the loop section of the saw which is attached to hooks when being used is repeatedly releasing from the crimped section and consequently meaning the saw is unusable. " it was indicated that this was a reoccurring problem over the last 6 months with products coming from this batch. The events caused slight delays in procedure (5 mins). Of the parts were received: 3 parts were used and had broken oval ferrules. However, the product remained in one piece. The loop simply opened up due to the failure of the ferrule. The other three saws were received unused in their original packaging. The product were returned to the supplier, (b)(4), for investigation. The ends which had not failed were retested. Although the average tested strength on 5 test pulls for batch ow067656 was (b)(4) and for ow068695 was (b)(4), and the minimum strength requirement is (b)(4), the results showed a great variation in load at break for ow068695. The press tool used to produce the device was inspected for wear and they found that it needed adjustment. Some of the parts were replaced and the tool was tested. The saw produced with the new tool failed at 55. 4 kg, well above the minimum. All saws from batch ow068695 which are in stock will be repressed before dispatch. Further, saws can be returned for rework if required. The event was recorded by (b)(4). See (b)(4) for further details. A worldwide complaint database search found several other related reports against the product code (962072000). However, none have been reported since the investigation was conducted by (b)(4) and implementation of their preventative action (adjustment of the press tool). We will continue to monitor per company protocol. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[138800213]
It was reported the gigli saw was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2019-87268 |
| MDR Report Key | 8420334 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-14 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-03-16 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2017-11-28 |
| Date Added to Maude | 2019-03-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 1210 WARD AVENUE |
| Manufacturer City | WEST CHESTER IN 193800988 |
| Manufacturer Country | US |
| Manufacturer Postal | 193800988 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIGLI SAW 50 CM |
| Generic Name | HIP INSTRUMENTS : SAW BLADES |
| Product Code | HSO |
| Date Received | 2019-03-14 |
| Returned To Mfg | 2018-05-14 |
| Catalog Number | 962072000 |
| Lot Number | OW068695 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY INTERNATIONAL LTD. 8010379 |
| Manufacturer Address | ST. ANTHONY'S RD LEEDS LS118 DT UK LS11 8 DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-14 |