MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL NAIL - YELLOW 9.3 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	N/A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.Device remains implanted.
Event or Problem Description
It was reported the patient presented back at the hospital with pain and complaining of impingement after insertion of a tibial nail.Surgeon suspects that nail length is causing the problem.No further information has been made available at this time.
Additional Manufacturer Narrative
The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further information has been made available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4: (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.It was reported that the nail implanted was too long but not changed at the point of surgery.The incorrectly sized nail can contribute to impingement and pain.The root cause of the reported issue is attributed to use error - incorrect length nail was implanted.Zimmer biomet offers a range of sizes to choose from.It is up to the surgeon's expertise to choose the appropriate size of the implant to match the patient's anatomy.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 is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.B3 ¿ unknown day in (b)(6) 2020.D7 ¿ unknown day in may 2020.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 that patient underwent nail procedure.Subsequently, the nail was explanted approximately 10 months later and no new metal ware was put in.No further event information is available at the time of this report.

• Brand Name: TIBIAL NAIL - YELLOW 9.3 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9445280
• Report Number: 0001822565-2019-05195
• Device Sequence Number: 14196285
• Product Code: HSB
• UDI-Device Identifier: 00889024097490
• UDI-Public: 00889024097490
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/10/2020

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: 47249532009
• Device Lot Number: 63744967
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 12/15/2019; 05/26/2020; 06/18/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 12/23/2019; 05/29/2020; 07/10/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention