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 2020-03-20 for ZIMMER SKIN GRAFT MESHER 00770100000 manufactured by Zimmer Surgical, Inc..
[184306819]
This event has been recorded under zimmer biomet complaint number (b)(4). On (b)(6) 2019, it was reported that the carrier would not fit into the mesher. The customer returned a skin graft mesher device, serial number (sn (b)(4)), for evaluation. The customer also returned a 3:1 ratio cutter, serial number (b)(4), and a ratchet handle, for evaluation. Product review of the skin graft mesher by flextronics on (b)(6) 2020 revealed the unit was out of calibration. The comb and comb springs were damaged, a bearing was loose, a screw was worn, and the stabilizer feet were damaged. The test mesh using the customer? S mesher and ratchet did not create a passing mesh. A cutter (3:1 1512465) was returned to flextronics and found to be defective. A ratchet was returned and passed visual inspection. Repair of the skin graft mesher was performed by flextronics on (b)(6) 2020 which included replacement of the comb (item #: 0600181044, lot # 64349426), comb springs (item #:06001810446, lot # 63138643), screw (item # 06001000134, lot # 63092218), stabilizer feet (item # 06001600158, lot # 63339482), and bearings (item # 06001810458, lot # 64025336). The unit was also recalibrated. Skin graft mesher, serial number ((b)(4)), was then tested and functioned properly. It was repaired, inspected and tested. The cutter was not repaired and was returned to the customer. It was determined that the cause of the carrier not fitting in the mesher was due to the device being out of calibration. However, it is unknown how the device became out of calibration. Therefore, a specific root cause cannot be determined. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Review of the information provided during the investigation determined that there are no further actions needed at this time (ie/capa/scar/hhe/d). This complaint will be tracked and trended for any adverse trends that may warrant further action.
Patient Sequence No: 1, Text Type: N, H10
[184306820]
It was reported that the zimmer skin graft carrier does not fit anymore into the zimmer skin graft mesher. The event did occurred during surgery. There was no harm or injury to patient or operator. There was a delay, but less then 15 minutes. Investigation identified that the device had a damaged comb. No adverse events were reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00300 |
| MDR Report Key | 9860505 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2011-03-08 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| 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 DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER SKIN GRAFT MESHER |
| Generic Name | EXPANDER, SKIN GRAFT, SURGICAL |
| Product Code | FZW |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-01-02 |
| Catalog Number | 00770100000 |
| Lot Number | 61734304 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |