MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3 10.5X100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3060-0100S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Hip Fracture (2349)
Date of Event	02/08/2021
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: "medial migration of gamma lag screw into patient¿s pelvis.Revision tha scheduled the (b)(6) 2021 to remove lag screw and replace hip.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the returned nail has explantation marks on the proximal surface.There are a few drill marks and bearing points at the distal drill hole of the received nail.There are also no prominent marks of set screw on the superior flute of the received lag screw which indicate that the set screw was not properly seated and locked.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.Regular post-operative examinations (e.G.X-ray checks) are advisable.The risk of post-operative complication (e.G.Failure of an implant) is higher if patients are obese and/or cannot follow the recommendations of the physician because of any mental or neuromuscular disorder.For this reason those patients must have additional post-operative follow-up.¿ based on investigation, the root cause was primarily attributed to a user related issue along with secondary patient factor issues (low activity level, former smoker, heavy alcohol intake).The migration of the lag screw happened due to inadequate insertion of the set screw inside the nail, leading to inadequate fixation of the lag screw with the set screw and setting it free.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "medial migration of gamma lag screw into patient¿s pelvis.Revision tha scheduled the (b)(6) 2021 to remove lag screw and replace hip.".

• Brand Name: LAG SCREW, TI GAMMA3 10.5X100MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11412220
• Report Number: 0009610622-2021-00318
• Device Sequence Number: 3947155
• Product Code: HSB
• UDI-Device Identifier: 04546540374943
• UDI-Public: 04546540374943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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 Expiration Date: 02/29/2024
• Device Model Number: 3060-0100S
• Device Catalogue Number: 30600100S
• Device Lot Number: K01BED9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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: 74 YR
• Patient Weight: 54