MAUDE Adverse Event Report: STRYKER GMBH CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 18066170

Device Problems Break (1069); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

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 tip of the extractor broke off.".

• Brand Name: CONICAL EXTRACTOR, MALE, LEFT HAND IMPLANT EXTRACTION SET 2.5 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: 18969298
• MDR Text Key: 338616432
• Report Number: 0009610622-2024-00108
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540510068
• UDI-Public: 04546540510068
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 18066170
• Device Lot Number: KSS1940H9
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1