MAUDE Adverse Event Report: STRYKER GMBH TELESCOPIC STRUT LONG HOFFMANN LRF LENGTH: 177-277MM (RED); APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49330180
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported by rep: "patient came in with ring fixator with two telescopic strut issues.One completely disconnected.Connter pin".The surgeon swapped out the 2 struts in his clinic the next day.
Event or Problem Description
As reported by rep: "patient came in with ring fixator with two telescopic strut issues.One completely disconnected.Connter pin." the surgeon swapped out the 2 struts in his clinic the next day.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was most probably caused by the misuse of the product.The two struts were returned.The pin is missing in one of the struts and partially coming out in the other strut.A product inspection was performed by the manufacturing team, the holes and the pin were manufactured according to the drawing's specifications.Moreover, the missing pin was replaced by a new pin, and tests to reproduce the event were made.A very large force was required in order to get the pin out of the hole.Therefore, the struts were likely handled with excessive forces and that the instructions for use for these implants were not followed.The ifu clearly states: "if the patient¿s activity comprises significant impact loads (walking, running, lifting or turning) the resulting forces could lead to failure of the fixation, the system or both.The system will not restore function to the level expected with normal healthy bone, and the patient should not have unrealistic functional expectations." moreover, the complaint reported that the patient was suffering from schizophrenia.The instructions for use highlighted the fact that mental illness may cause the patient to ignore certain necessary limitations and precautions in the use of the device, leading to failure or other complications.The ifu states: "conditions presenting an increased risk of failure include: mental, physical or neurological conditions which may impair the patient¿s ability to cooperate with the postoperative regimen." therefore, this case is classified as a patient related issue.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.If any further information is provided, the investigation report will be updated.

• Brand Name: TELESCOPIC STRUT LONG HOFFMANN LRF LENGTH: 177-277MM (RED)
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8809866
• Report Number: 0008031020-2019-00905
• Device Sequence Number: 19619797
• Product Code: KTT
• UDI-Device Identifier: 07613252610236
• UDI-Public: 07613252610236
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K113327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 49330180
• Device Lot Number: D13837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/20/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR