MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VARIABLE LOCK SCREW 4.75X40MM ORTHOPAEDIC BONE PIN

Catalog Number 180355

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scar Tissue (2060); Synovitis (2094); Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 06/19/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: maestro radial stem 6. 0x40mm cat# 180181 lot# 172020. Maestro tc carpalhd 7x15mm std cat# 180363 lot# 706680. Maestro tc capitatestem 6x15mm cat# 180321 lot# 827400. Maestro rad w/brg 7x15 7. 5 lt cat# 180150 lot# 265820. Maestro tc carpalpt 9x37 12 ag cat# 180305 lot# 466030. Variable lock screw 4. 75x15mm cat# 180350 lot# 438530. Cobalt mv bone cement 40gm b cat# 402439 lot# 589540. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03690. 0001825034 - 2020 - 03691. 0001825034 - 2020 - 03692. 0001825034 - 2020 - 03693. 0001825034 - 2020 - 04061. 0001825034 - 2020 - 04063. 0001825034 - 2020 - 04064.

Event Description

It was reported that the patient underwent a left wrist arthroplasty. Subsequently, the patient was experiencing sharp pains, weakness and limited range of motion (rom), leading to medication, physical therapy, and monthly doctor visits for approximately 2 years post op. Further, the patient experienced loss of extension in the wrist due to rheumatoid arthritis, flexion contracture, and tendon tear. Nearly 3 years after initial surgery, a left wrist extensive extensor tendon tenolysis, extensor carpri radialis longus transfer, repair of extensor digitorum was performed, and manipulation of left wrist. The soft tissue correction procedure was completed without complication. The surgeon noted the patient had a complete rupture of all tendons of the extensor digitorum communias as well as the extensor carpi radialis brevis tendons. Further, the patient had severe scarring around the site of the previous surgery. All hardware was intact, in proper position, and left in place. Since the procedure, the patient has reported ongoing pain and limited range of motion. A revision procedure is indicated as necessary; however, no revision procedure has been reported to date. Attempts have been made and additional information is unavailable at the time of this report.

• Brand Name: VARIABLE LOCK SCREW 4.75X40MM
• Type of Device: ORTHOPAEDIC BONE PIN
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 10822330
• MDR Text Key: 215941438
• Report Number: 0001825034-2020-04062
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 180355
• Device Lot Number: 438580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data

Patient Treatment Data

Date Received: 11/11/2020 Patient Sequence Number: 1