MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL NAIL RETRO; PROSTHESIS, TRAUMA

Catalog Number	14-444342
Medical Device Problem Codes	Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: part#14-442019 lot#unk.Part#14-442021 lot#unk.Part#14-442088 lot#unk.Part#29407 lot#unk.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 has been reported patient underwent surgery approximately three (3) weeks ago.While doctor was inserting nail, the nail came off of the inserter jig.Doctor extracted nail, attempted to reattach it, and it came off again.Doctor then screwed the core lock all the way down hoping it would create more room for the connecting bolt, but the nail still would not attach properly to the jig.Sales rep brought a second set of instruments into the room to see if there was a possible problem with the bolt or jig.He tried using the second set of instruments and the nail would still not attach properly.Doctor ended up using a different nail and it had attached perfectly and was able to be implanted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FEMORAL NAIL RETRO
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10025601
• Report Number: 0001825034-2020-01870
• Device Sequence Number: 16878191
• Product Code: HSB
• UDI-Device Identifier: 00888480166993
• UDI-Public: (01)00888480166993
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072161
• 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): 09/08/2020

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: 14-444342
• Device Lot Number: 582190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 09/09/2020
• 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
• Patient Age: 37 YR