MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 13200233

Device Problems Problem with Sterilization (1596); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device disposition is unknown.

Event Description

The following report was submitted by bfarm: the information received indicates that the hospital was not satisfied with the sterility of the device after the reprocessing process.The initial reporter indicated that the "structural design of the medical device does not allow visual inspection for residual contamination after machine cleaning and disinfection.Any residual contamination is a danger to the patient.The manufacturer cannot provide any special processing instructions for this medical device.The general reprocessing instructions for reusable medical devices of the manufacturer apply.".

• Brand Name: SET SCREWDRIVER, FLEXIBLE SHAFT GAMMA3® 4 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9177191
• MDR Text Key: 191805196
• Report Number: 0009610622-2019-00863
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540592545
• UDI-Public: 04546540592545
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2019

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 Catalogue Number: 13200233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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