MAUDE Adverse Event Report: BIOMET TRAUMA AFFIXUS HIP FRACTURE NAIL 125 DEG 9MM X 180MM ROD, FIXATION

Model Number N/A

Device Problems Failure to Disconnect (2541); Device Operational Issue (2914)

Patient Problem No Code Available (3191)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Product has been returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Corrected: model #/lot #: lot number: 153150 or 153160, expiration date: apr 25, 2027 or apr 24, 2027. Complaint sample was evaluated and the reported event was confirmed. The returned device is one 125-degree affixus hip fracture nail, pn 814309180 ln 5550103, along with the associated 125-degree targeting jig and connecting bolt. Visually, the nail and jig are unremarkable, with a small amount of cosmetic wear likely due to implantation, explantation, and sterilization. The connecting bolt shows wear - but not to the point of being stripped. Functional testing reveals the bolt to be fused to the nail, confirming this complaint. The lot number etched on the device, 5550103, corresponds to the component part 814309180-00. A review of manufacturing records shows that this was issued to two finished goods lots of item 814309180, lot 153150 and lot 153160. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action(s) is/are required. Root cause was unable to be determined. 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.

Manufacturer Narrative

(b)(4). Medical product - insertion jig 125 degree, cat#: 211201200 lot#: e73df4. 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: 0001825034-2017-05191 and 0001825034-2017-05197.

Event Description

It was reported that during a hip fracture nailing procedure, the connecting jig bolt was locked in the nail and could not be dislodged or removed. As a result, the entire system had to be removed from the patient. A competitor product was used to complete the procedure with minimal delay. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: AFFIXUS HIP FRACTURE NAIL 125 DEG 9MM X 180MM
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): BIOMET TRAUMA; 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: 6739504
• MDR Text Key: 109930768
• Report Number: 0001825034-2017-05191
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK100238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 814309180
• Device Lot Number: SEE H10 NARRATIVE
• Other Device ID Number: (01) 00887868037962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 07/25/2017 Patient Sequence Number: 1