MAUDE Adverse Event Report: STRYKER TRAUMA KIEL END CAP T2 TIBIA +5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1822-0005S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It has been reported by the customer that, upon placing the end cap ((b)(4)), it didn't fit properly and when it was removed, it was observed that the threads were damaged.It was attempted to place a second tap ((b)(4)) and the same thing happened.So finally no cap was placed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned device reveals damage to the end cap threads.The device inspection revealed the following: severe damage to end cap threads were observed.End cap threads are compressed.Damage is consistent with abrasive impact on a hard material.Dimensional inspection: due to the nature of the returned device, a dimensional inspection was not possible on the end cap thread.Dimensional inspection on other locations on the end cap were confirmed to be within specification.However, during manufacturing; functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by inadequate alignment of end cap during insertion.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It has been reported by the customer that, upon placing the end cap ref.(b)(4), it didn't fit properly and when it was removed, it was observed that the threads were damaged.It was attempted to place a second tap ref.(b)(4) and the same thing happened.So finally no cap was placed.

• Brand Name: END CAP T2 TIBIA +5 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9434347
• Report Number: 0009610622-2019-00951
• Device Sequence Number: 16571816
• Product Code: HSB
• UDI-Device Identifier: 04546540197559
• UDI-Public: 04546540197559
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1822-0005S
• Device Catalogue Number: 18220005S
• Device Lot Number: K0DED39
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1