MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONNECTING BOLT; PROSTHESIS, TRAUMA

Catalog Number	14-440042
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign - event occurred in (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00918.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that an operation was performed with a phoenix ankle nail.During the procedure, the connecting portion between the nail and bolt had come off when the surgeon inserted the nail into the patient.The surgeon removed the nail and tried to connect the nail with the bolt; however, it couldn't reconnect.Surgeon then used a backup nail to finish the operation.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the threads on both bolt and nail are stripped.The bolt has a potential field age of 8 years.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 report 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d4; d10; g4; g7; h1; h2; h4; h6.During investigation, the part # was found to be 14-440042 and lot # is noted to either be: 715780 or 967750.The following sections could not be completed because the lot information cannot be confirmed: h4 - manufacturing date - lot: 715780 - october 6, 2011.H4 - manufacturing date - lot: 967750 - october 21, 2011.The investigation is still in progress.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.

• Brand Name: CONNECTING BOLT
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9774672
• Report Number: 0001825034-2020-00919
• Device Sequence Number: 525240
• Product Code: LXH
• UDI-Device Identifier: 00887868093241
• UDI-Public: (01)00887868093241
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2020

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: 14-440042
• Device Lot Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 05/15/2020; 06/10/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 05/21/2020; 06/11/2020
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANKLE NAIL CATALOG#: 14-440221 LOT#: 244390.