MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DERMATOME AN HANDPIECE

Model Number N/A

Device Problems Circuit Failure (1089); Incorrect, Inadequate or Imprecise Result or Readings (1535); Noise, Audible (3273); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).Once an investigation of this device is completed, a follow-up/final report will be submitted.Three devices were reported to us on this complaint, though it is unknown which exact device was exhibiting the reportable malfunction of harvesting skin thicker than desired.To make up for this, all three devices will be listed below, and a follow-up/final report will be submitted to clarify precisely which device was harvesting skin excessively.Item#: 88710100; lot#: 64324677; serial#: (b)(4), manufacture date: unk, sterile expiry date: unk, udi: unk, fda class code: i; 510k: exempt; fda product code: gfd; mdl #: c041134 qty: 1.Or item#: 88710100; lot#: 64367743; serial#: (b)(4), manufacture date: unk, sterile expiry date: unk, udi: unk, fda class code: i; 510k: exempt; fda product code: gfd; mdl #: c041134 qty: 1.Or item#: 00-8851-002-06, lot#: 64454759, serial#: (b)(4), manufacture date: unk, sterile expiry date: unk, udi: unk, fda class code: i; 510k: exempt; fda product code: gfd; mdl #: c041134, qty: 1.(b)(6).Dr.(b)(6).

Event Description

It was reported that they checked the machine and found out that the motor was stuck and the motor controller was burnt (shorted) due to the moisture and wet motor controller.Additional information was later acquired that during surgery, a dermatome was very noisy.Another device was found, which was also found to be too noisy.It was also reported that one of these device was harvesting skin thicker than desired, however it is unknown by the customer which of the devices being returned was behaving this way.There was a 15-30 minute delay.The event occurred in april 2020, but an exact date is not known.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.D4: three devices were reported to us on this complaint, though it is unable to be determined which exact device was exhibiting the reportable malfunction of harvesting skin thicker than desired.Item#: 88710100; lot#: 64324677; serial#: (b)(6).Manufacture date: 14-feb-2019.Sterile expiry date: unk.Udi: (b)(4).Fda class code: i; 510k: exempt; fda product code: gfd; mdl #: c041134.Qty: 1.Or item#: 88710100; lot#: 64367743; serial#: (b)(6).Manufacture date: 22-mar-2019.Sterile expiry date: unk.Udi: (b)(4).Fda class code: i; 510k: exempt; fda product code: gfd; mdl #: c041134.Qty: 1.Or item#: 00-8851-002-06, lot#: 64454759, serial#: (b)(6).Manufacture date: 9-july-2019.Sterile expiry date: unk.Udi: (b)(4).Fda class code: i; 510k: exempt; fda product code: gfd; mdl #: c041134.Qty: 1.Sn (b)(6): review of the most recent repair record determined the unit was out of calibration and the control bar was not in the correct position.The unit was recalibrated and resolved the reported issue.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The event is confirmed.Sn (b)(6): review of the most recent repair record determined the unit was out of calibration and the control bar was not in the correct position.The control bar was replaced and resolved the reported issue.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.The event is confirmed.Sn (b)(6): no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Review of complaint history found no additional related issues for this item and the reported part and lot combination.The event cannot be confirmed.All sn's: device(s) is/are used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: DERMATOME AN HANDPIECE
• Type of Device: DERMATOME
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 10282819
• MDR Text Key: 199505873
• Report Number: 0001526350-2020-00613
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SEE H10 NARRATIVE
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1