MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0X 7MM DIR-DRV LACT SCW 2PK; PROSTHESIS, MICROFIXATION

Catalog Number	915-2201
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00109, 0001032347-2021-00111, 0001032347-2021-00112, 0001032347-2021-00113, 0001032347-2021-00114.Device available for evaluation: item# 915-2201; lot# 893730, item# 915-2200; lot# 862630, item# 915-2200; lot# 862630, item# 915-2200; lot# 862630, item# 915-2200; lot# 862630.Item# unk screwdriver; lot# unk foreign report source: (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 approximately three (3) weeks ago, that the surgeon tried to grip the screw with a screwdriver and the fit was too tight.As a result, the screw head broke.The surgeon opened a new screw to complete the surgery.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d9; g3; g6; h1; h2; h3; h6 6 screws were returned for evaluation.A quantity of 2 screws for 915-2201 lot 893730 were returned.Those screws are not fractured.All 6 screw threads were visually inspected and none of the threads are damaged.No measurements were taken on the product as all have been used with the driver at some point after leaving zimmer biomet control.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined due to the inability to measure the dimensions the product due to attempted use.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
No further event information available at the time of this report.

• Brand Name: 2.0X 7MM DIR-DRV LACT SCW 2PK
• Common Device Name: PROSTHESIS, MICROFIXATION
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11440676
• Report Number: 0001032347-2021-00110
• Device Sequence Number: 14333591
• Product Code: HWC
• UDI-Device Identifier: 00841036125479
• UDI-Public: (01)00841036125479
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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 Catalogue Number: 915-2201
• Device Lot Number: 893730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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