MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM TIBIA T2 ALPHA? TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 23534107

Device Problems Crack (1135); Fracture (1260)

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

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

Field warehouse team noticed that the knob of the tibia targeting arm is cracked.The device is still functional.Not known when or under what circumstances the device cracked.

Event Description

Field warehouse team noticed that the knob of the tibia targeting arm is cracked.The device is still functional.Not known when or under what circumstances the device cracked.

Manufacturer Narrative

Visual inspection was limited to the image of the device.Based on the image provided a crack could be verified at the grey tightening knob.The dhr of the reported tibia target device revealed no manufacturing discrepancies.Further investigation determined that the crack was caused by a manufacturing agent used by a contract manufacturer.This is being investigated as a nonconformity.

• Brand Name: TARGETING ARM TIBIA T2 ALPHA? TIBIA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8804435
• MDR Text Key: 151711998
• Report Number: 0009610622-2019-00541
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327357080
• UDI-Public: 07613327357080
• Combination Product (y/n): N
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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: 23534107
• Device Lot Number: KME912431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1