MAUDE Adverse Event Report: BIOMET UK LTD. TPRLC RASP PROV 6MM; BONE RASP

Model Number N/A

Device Problem Break (1069)

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

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Concomitant medical products: exact offset broach handle, catalog #:31-555501, lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the instrument fractured (metal piece detached).The fractured metal piece was completely removed from the patient.No delay to the procedure.Not known impact or consequences to the patient or the user.

Event Description

It was reported that the instrument fractured (metal piece detached).The fractured metal piece was completely removed from the patient.No delay to the procedure.Not known impact or consequences to the patient or the user.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found no similar complaints reported with this item 31-600309.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product not returned.

Event Description

It was reported that the instrument fractured (metal piece detached).The fractured metal piece was completely removed from the patient.No delay to the procedure.No known impact or consequences to the patient or the user.

Manufacturer Narrative

(b)(4).This follow-up final report is being submitted to relay additional information.Complaint summary: when rasping with the taperloc rasp (31-600309 raspel taperloc 6mm), a metal piece detached itself from the rasp.The metal piece was completely removed from the patient.This occurred in surgery.A visual check of the returned product taperloc rasp provisional 6mm (item 31-600309 lot.Zb170402) confirms that distal end has fracture off.The distal end piece has not been returned, and the rasp has wear on the teeth and on the face of the proximal end where the rasp handle attaches.A dimensional inspection is not required for this event as it is for a fracture issue.The most likely root cause is wear and tear due to being used in many surgical procedures over time in the field but this cannot be confirmed.The reusable instrument lifespan manual, provides instruction within the introduction section headed inspection/function testing to guide the user on how to check instruments for completeness and function.Visual examples of damage can be seen in the section headed fracture.This product most likely left zimmer biomet control conforming, as it has been used for an unconfirmed period prior to this event.A visual inspection of this device shows this event does not differ from previous reported events for the taperloc rasp provisional 6mm (31-600309 lot no.Zb170402).As a result, there is no change to the severity or occurrence for this event and the reported event is still considered to be within the severity of the risk file.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TPRLC RASP PROV 6MM
• Type of Device: BONE RASP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 9810439
• MDR Text Key: 200624659
• Report Number: 3002806535-2020-00126
• Device Sequence Number: 1
• Product Code: HTR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-600309
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1