MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X7MM HT SD X-DR SCR 5-PK; PROSTHESIS, MICROFIXATION

Catalog Number	95-6107
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00336.Concomitant medical products: item# 95-6107; lot# 823870.Item# 95-6107; lot# 823870.Item# 95-6107; lot# 823870.Item# 95-6107; lot# 823870.Item# 95-6107; lot# 823870.(b)(6).Report source: foreign - event occurred in (b)(6).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 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 during an initial procedure approximately six (6) weeks ago, two (2) of the six (6) nails being used broke and was retained by the patient.One screw broke while being inserted and the second screw did not seat properly and broke when the surgeon tried to remove it.Patient has not experienced any post-surgery complications.Attempts have been made and no further information has been provided.
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; g3; g6; h1; h2; h3; h6 no product was returned.However, a visual inspection was conducted on the customer provided pictures.The screws both show heavy signs of use.There is heavy marking on both screw heads.Both screw shafts have fractured.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

• Brand Name: 1.5X7MM HT SD X-DR SCR 5-PK
• Common Device Name: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11938923
• Report Number: 0001032347-2021-00335
• Device Sequence Number: 4226420
• Product Code: JEY
• UDI-Device Identifier: 00841036056681
• UDI-Public: (01)00841036056681
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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 Catalogue Number: 95-6107
• Device Lot Number: 823870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR