MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for GIGLI SAW HANDLES 00036700000 manufactured by Zimmer, Inc..
[67399346]
The following could not be completed with the limited information provided. Age or date of birth? Na, weight? Na, device product code - hso, expiration date - na, date implanted - na, date explanted - na, initial reporter - na. The product was not returned for review; therefore the exact condition of the device is unknown. The device history records for the handles were reviewed and identified no deviations or anomalies. Assembly traceability record indicates 20 pieces issued; this should be 40. The product is supposed to be and was historically packaged from the supplier two per box. The product is denoted as boxes, rather than labeled as pieces or each. This is also why the assembly traceability record calls for a standard quantity of 20. When the assembly traceability calls for 20, it is meant to be 20 of the aforementioned boxes (2 per) from the supplier. It was confirmed that the packager made the decision to change the packaging to the lollipop style instead of the historical two per box, as the puller was not an experienced operator and made the mistake due to the "new" packaging coming from the supplier. Stock investigation was completed on the remaining 9 pieces within inventory for lot 63200704 and found all 9 pieces to be non-conforming. Qh16000132 was issued to contain this lot. This device is used for treatment. Initial product history search was conducted and revealed no additional complaints against the related part and lot combination. The most likely cause of the incorrect quantity packed was supplier error. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
Patient Sequence No: 1, Text Type: N, H10
[67399347]
It is reported that when the packaging was received for the two gigli saw handles, only one handle could be found in the package. The saw could not be used with only one handle. There was no reported delay to procedure due to the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-00556 |
| MDR Report Key | 6324297 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-02-03 |
| Date of Event | 2016-08-19 |
| Date Mfgr Received | 2017-01-13 |
| Device Manufacturer Date | 2015-09-21 |
| Date Added to Maude | 2017-02-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GIGLI SAW HANDLES |
| Generic Name | TRAUMA INSTRUMENT |
| Product Code | HSO |
| Date Received | 2017-02-10 |
| Model Number | NA |
| Catalog Number | 00036700000 |
| Lot Number | 63200704 |
| ID Number | NA |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-10 |