MAUDE Adverse Event Report: ZIMMER TMT CURVED OSTEOTOME; INSTRUMENT, SURGICAL

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device identified that the clamping screw was no longer functioning as intended, as it would not tighten.The hex threads inside the screw were damaged likely from tightening the screw.The device had an approximate field life of 3 years.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Report source: event occurred in (b)(6).
Event or Problem Description
It was reported that during a primary tha, the instrument would not hold the blade component.The surgeon was unable to use the device and proceeded to use a chisel for surgery.This resulted in a 31-60 minute delay in surgery.Attempts have been made and no further information has been provided.

• Brand Name: CURVED OSTEOTOME
• Common Device Name: INSTRUMENT, SURGICAL
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9631457
• Report Number: 3005751028-2020-00008
• Device Sequence Number: 17005717
• Product Code: HWM
• UDI-Device Identifier: 00889024311954
• UDI-Public: (01)00889024311954
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00705300301
• Device Lot Number: 63396488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization