MAUDE Adverse Event Report: STRYKER TRAUMA KIEL END CAP T2 GTN +10MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18500010S

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

In (b)(6) 2016, implant the t2 nail with no issue.On (b)(6) 2017, there was confirmed no issue by x ray on follow up.On (b)(6) 2017, there was occured the end cup was back out.On (b)(6) 2017, it was performed revision surgery to remove the end cup and replaces new end cup.There are no pseudo joints, and follow-up observation will be performed.

Manufacturer Narrative

Referring to the product inquiry the end cap t2 gtn +10mm is the primary product.No further associated products were reported.A review of the device history records for the reported end cap revealed no discrepancies; no material or manufacturing related issues were found.The end cap received shows slight traces of usage but no damage.It is in good general condition.A comprehensive dimensional examination with the appropriate test equipment revealed no deviations; all relevant dimensions were found to be within specified tolerances.Furthermore, the end cap received was checked with a sample nail and locking screw.It could be inserted without problem as intended.It could also be tightened down onto the (sample) oblique locking screw at the driving end of the nail as described in the operation manual.The item was found to be fully functional.In the case presented a (b)(6) year-old patient was treated with a t2 gtn nail on (b)(6) 2016.In (b)(6) 2017 during follow-up visit x-rays showed no implant failure.On (b)(6) 2017 it was detected that the end cap has backed out.On (b)(6) 2017 the end cap was replaced by a new one.X-rays have been requested but were not available.No further information was received.Based on the above observations the root cause of the reported event is not linked to a deficiency of the device.With the limited information given a more precise statement is not possible.The root cause of the reported event could not be determined.Review of complaint history, capa databases, risk analysis and the labelling did not identify any conspicuity.There are no open actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

On (b)(6) 2016 implant the t2 nail with no issue.On (b)(6) 2017, there was confirmed no issue by x ray on follow up.On (b)(6) 2017, there was occured the end cup was back out.On (b)(6) 2017, it was performed revision surgery to remove the end cup and replaces new end cup.There are no pseudo joints, and follow-up observation will be performed.

• Brand Name: END CAP T2 GTN +10MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 6687395
• MDR Text Key: 79080800
• Report Number: 0009610622-2017-00205
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K101438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 18500010S
• Device Lot Number: K0CF171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 34