MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30600085S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was discarded.
Event or Problem Description
It was reported that on (b)(6) 2018 a long gamma nail was implanted.During follow up 2 weeks after surgery, and there was no problem.However due to fall over on (b)(6) 2019, patient was complaining of pain.During revision surgery on (b)(6) 2018 cut out the screw was discovered.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences like x-rays, surgery reports were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned and the lot number was not communicated.The reported lag screw has been implanted about a year ago on (b)(6), 2018 and was reported to be backed out after a fall of the patient on (b)(6), 2019.In this case, follow-up after surgery had already indicated that there was no problem observed after 2 weeks.After approx.7 months cutout had finally occurred.Thus, the patient¿s post-operative activity (fall) had contributed to the event.Based on investigation, the root cause was attributed to patient related issue.The failure was caused by patient fall and sudden increase in the load application on the implant.A review of the labeling did not indicate any abnormalities.Based on the given information a deficiency of the lag screw could not be verified.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that on (b)(6), 2018 a long gamma nail was implanted.During follow up 2 weeks after surgery, and there was no problem.However due to fall over on (b)(6) 2019, patient was complaining of pain.During revision surgery on (b)(6) 2018 cut out the screw was discovered.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X85MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8392760
• Report Number: 0009610622-2019-00093
• Device Sequence Number: 11175546
• Product Code: HSB
• UDI-Device Identifier: 04546540374912
• UDI-Public: 04546540374912
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 30600085S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 04/26/2019
• 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