MAUDE Adverse Event Report: BIOMET MICROFIXATION LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP; TAP, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00271, 0001032347-2020-00272.Medical products: 1.5mm system twist drill with j notch 1.1 x 50mm, 9mm stop, part# 01-7146, lot# ni.Lactosorb system 1.5mm adjustable self-drilling tap, part# 915-1595, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source - (b)(6).
Event or Problem Description
It was reported the drill and tap fractured during surgery.The procedure was completed using an alternative drill and tap.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.The device was returned for investigation.Visual evaluation showed it was fractured near the neck, at the start of the fluted section.The non-conformance database was reviewed for the tap; no non-conformances were found.This is the only complaint for this item# 915-1595, vendor lot# 532852.The most likely underlying cause of the complaint is that excessive force was applied, in excess of what the instrument was designed to encounter.It is possible that the instrument was used over the maximum recommended speed, it was used to tap into high density bone, excessive normal force was applied during tapping, or off-axis forces were applied during tapping.There are no indications of manufacturing defects.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
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D11 ¿ medical products.1.5mm system twist drill with j notch 1.1 x 50mm, 9mm stop, part# 01-7146, possible lot numbers# 255860, 061220, 394390, 394370, 623130, 623100, 894590, 894520, 894500, 894450, 894250, 714360, and 229520.Lactosorb system 1.5mm adjustable self-drilling tap, part# 915-1595, lot# 532852.

• Brand Name: LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP
• Common Device Name: TAP, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10165558
• Report Number: 0001032347-2020-00272
• Device Sequence Number: 2653919
• Product Code: HWX
• UDI-Device Identifier: 00841036125653
• UDI-Public: 00841036125653
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2020

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 Model Number: N/A
• Device Catalogue Number: 915-1595
• Device Lot Number: 532852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 09/02/2020; 10/25/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 09/22/2020; 10/27/2020
• 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