MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RETRO FEMUR MOD TARG GUIDE; INSTRUMENT, TRAUMA

Catalog Number	00249000430
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02562, 0001822565-2020-02561, 0001822565-2020-02876.Concomitant medical devices: item# 00249000424; lot# 61793873; item# 00249000432; lot# 63206145; item# 00249000431; lot# 63199333.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Event or Problem Description
It was reported approximately three (3) months ago during an initial surgery, the retrograde nail jig attachment would not line up to the proximal holes.There was a 35 minute delay.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified damages in the form nicks and scratches indicating usage of the devices.The dimensional analysis of the targeting guide was conforming to specifications during manufacturing.The device was assembled without any difficulty.The devices has 5 and 9 years of field service age and it is unknown how many times the device was used.The nail was not returned and it is cannot be confirmed the orientation and placement of the nail jig.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: RETRO FEMUR MOD TARG GUIDE
• Common Device Name: INSTRUMENT, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10392019
• Report Number: 0001822565-2020-02875
• Device Sequence Number: 19557925
• Product Code: HSB
• UDI-Device Identifier: 00889024062924
• UDI-Public: (01)00889024062924
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00249000430
• Device Lot Number: 63210804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1