MAUDE Adverse Event Report: STRYKER GMBH GUIDE WIRE, BALL-TIPPED T2 Ø2.5X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 18060084S

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "the nail was not implanted, [wire] twisted in the original box.".

• Brand Name: GUIDE WIRE, BALL-TIPPED T2 Ø2.5X1000 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18981712
• MDR Text Key: 338709888
• Report Number: 0009610622-2024-00112
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613154172573
• UDI-Public: 07613154172573
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18060084S
• Device Lot Number: K170817
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1