MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RETRO FEM CONNECTING BOLT; SURGICAL INSTRUMENT

Model Number	14-442021
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 14-444236 fem nail retro 10.5mm x 360mm 210200; 14-442019 retrograde fem nl driver unknown.Foreign- (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03653.
Event or Problem Description
It was reported that during surgery when the physician tried to put a retrograde nail, the driver nose pulled out of the nail.The surgeon had to extract the nail as the thread of the bolt was short and hence resulted in a surgical delay of two hours.
Event or Problem Description
Upon reassessment of the reported event, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.

• Brand Name: RETRO FEM CONNECTING BOLT
• Common Device Name: SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10600399
• Report Number: 0001825034-2020-03654
• Device Sequence Number: 3232343
• Product Code: LXH
• UDI-Device Identifier: 00887868094309
• UDI-Public: (01)00887868094309
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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 Model Number: 14-442021
• Device Catalogue Number: 14-442021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10