MAUDE Adverse Event Report: . MIH CURVED ACET REAMER DRIVER; INSTRUMENT, HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 07/26/2018

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 that while surgeon was performing a total hip arthroplasty the reamer connection end broke off while reaming the acetabulum.Surgery was completed with a straight reamer handle, which was also in the set and no delay in surgery occurred.Attempts were made to obtain additional information; however, none was available.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection confirmed that the connection is fractured from the remainder of the inserter.Surface scratching was observed through the entire device.Supplier dhr was not requested as the severity is 1 and the device functioned as in tended for the life span of 11-13-2006 to 7-22-2018 when the complaint was created so it is unlikely the alleged event was manufacturing related.Review of the certificate for part # 31-555524 with lot 350501 identified no deviations or anomalies.All records show that the lot was received according to specifications.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: MIH CURVED ACET REAMER DRIVER
• Type of Device: INSTRUMENT, HIP
• Manufacturer (Section D): .; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7782350
• MDR Text Key: 117136819
• Report Number: 0001825034-2018-04977
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

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 Model Number: N/A
• Device Catalogue Number: 31-555524
• Device Lot Number: 350501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1