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

Catalog Number 18060084S

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/02/2019

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Discarded by the customer.

Event Description

The hospital reported the following event : "before the use of the tibia nail guide the pharmacist noticed that the inner packaging was damage.Deteriorated inner packaging, therefore non-sterile implant.According to the pharmacist at the reception the box was not damage, it was only the inner packaging.The incriminated device was discarded they use another tibia nail guide to performed the intervention.No surgical delay, no adverse consequences, no medical intervention.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Ifu points out as following: 'caution: inspection is recommended prior to surgery to determine if instruments or implants have been damaged during storage or prior procedures.' in case the item and / or substantive information will become available in future the file will be updated accordingly.

Event Description

The hospital reported the following event : "before the use of the tibia nail guide the pharmacist noticed that the inner packaging was damage.Deteriorated inner packaging, therefore non-sterile implant.According to the pharmacist at the reception the box was not damage, it was only the inner packaging.The incriminated device was discarded.They use another tibia nail guide to performed the intervention.No surgical delay, no adverse consequences, no medical intervention.

• Brand Name: GUIDE WIRE, BALL-TIPPED T2 TIBIA Ø2.5X1000 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8453843
• MDR Text Key: 140144709
• Report Number: 0009610622-2019-00127
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613154172573
• UDI-Public: 07613154172573
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 18060084S
• Device Lot Number: K05B20A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other