MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER TM REVERSE SHOULDER SYSTEM PIN 2.5 MM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Concomitant medical product: tm reverse shoulder system base plate drill guide 1, cat#: 00430904300, lot#: 62629450.Complaint sample was evaluated and the reported event was confirmed.The pin is fractured and bent, and exhibits grooves, galling and a dull point.A portion of the pin also remains seized in the hole of the base plate drill guide.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.A definite root cause cannot 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.Multiple mdr reports were filed for this event, please see associated report: 0001822565-2017-02726.

Event Description

It is reported that during a total shoulder arthroplasty procedure, the pin spot-welded into the drill guide on the first use of the drill guide.No adverse events have been reported as a result of the malfunction.

• Brand Name: ZIMMER TM REVERSE SHOULDER SYSTEM PIN 2.5 MM
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6520820
• MDR Text Key: 73670793
• Report Number: 0001822565-2017-02725
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 47430902501
• Device Lot Number: 63399401
• Other Device ID Number: SEE H10 SUMMARY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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 Sequence Number: 1
• Patient Age: 46 YR