MAUDE Adverse Event Report: BIOMET MICROFIXATION MODIFIED BECK ELEVATOR; INSTRUMENT

Catalog Number SP-2359

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

It was reported the instrument broke during surgery.No harm to patient or surgical delay was reported.

Event Description

No further event information is available at this time.

Manufacturer Narrative

Visual examination of the returned product identified item#: sp-2359, lot# b20 (021020b20) was returned and also confirmed the reported fracture at the tip of the instrument.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The device was returned to the supplier for evaluation.The supplier tested the hardness and determined the value was within the specifications.The supplier also stated the fracture point shows that the instrument was not used according to the purpose and the instrument must not be used as a level.Due to the special shape, an over-strengthening of the tip can cause breakage.No medical records were supplied with the complaint, therefore no comments can be made regarding the surgical technique.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.

• Brand Name: MODIFIED BECK ELEVATOR
• Type of Device: INSTRUMENT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11300460
• MDR Text Key: 238622062
• Report Number: 0001032347-2021-00036
• Device Sequence Number: 1
• Product Code: EMJ
• UDI-Device Identifier: 00841036138998
• UDI-Public: (01)00841036138998
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: SP-2359
• Device Lot Number: 021020B20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1