MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPRESS DRILL GUIDE SMALL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 32-481003

Device Problems Bent (1059); Misassembled (1398)

Patient Problem No Information (3190)

Event Date 12/29/2016

Event Type  malfunction  

Manufacturer Narrative

The lot identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Concomitant medical product- biomet compress anchor plug 10mm, catalog#: 178400, lot#: unknown.

Event Description

During the procedure, the instrument was noticed to have a bent and cross threaded component during implantation of the anchor plug.It could not tighten or be taken out with a vice grip.It delayed the case 20 minutes, while the surgeon went up to a size 14 small anchor plug in order to use the large compress drill guide instead of the small drill guide.

Manufacturer Narrative

Concomitant medical products - medical product: compress device short anchor plug, cat#: 178552, lot#: 500730.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: COMPRESS DRILL GUIDE SMALL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6287520
• MDR Text Key: 66113119
• Report Number: 0001825034-2017-00222
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 32-481003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Weight: 35