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

Catalog Number 95-6107

Device Problems Fracture (1260); Difficult to Insert (1316)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/20/2021

Event Type  Injury  

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 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 Description

No further event information available at the time of this report.

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
• Type of Device: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11938923
• MDR Text Key: 254328679
• Report Number: 0001032347-2021-00335
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036056681
• UDI-Public: (01)00841036056681
• Combination Product (y/n): N
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 95-6107
• Device Lot Number: 823870
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR