MAUDE Adverse Event Report: STRYKER GMBH RC LAG SCREW GAMMA4 Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660090S
Medical Device Problem Codes	Positioning Failure (1158); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
T was reported that due to the malfunction of the device, which led to intra-operative event that resulted in additional larger incision and device replacement.The actual severity of s2 was assigned to the harm of the complaint because the reported event led to a minor intra-op intervention to prevent permanent impairment.
Event or Problem Description
It was reported that due to the malfunction of the device, which led to intra-operative event that resulted in additional larger incision and device replacement.The actual severity of s2 was assigned to the harm of the complaint because the reported event led to a minor intra-op intervention to prevent permanent impairment.
Additional Manufacturer Narrative
The reported event could be confirmed, since the visible damages confirm the event description.The complete rc lag screw including u-blade and end cap were returned for evaluation.The visual inspection has shown that one leg of the u-blade is deformed and that there are two slight cracks visible at the crossover to the end piece.It looks like the u-blade was pushed very hard while it was stuck at the forefront, this did lead to a compression of the legs which had the effect that the leg was pushed outwards.At the tips of the u-blade legs are strong deformations visible, they also indicate that the u-blade was pushed very hard while it was stuck in this area.The anodized layer is not present any more at the damages, which shows that they were caused post-manufacturing.The inspection of the lag screw has shown that both grooves are completely intact, there is absolutely no indication that the u-blade was ever inserted into the grooves.Also, on the top of the lag screw are absolutely no marks from a contact with the u-blade visible.Looking at the damage on the u-blade tips, you would expect similar damages at the lag screw.But there is no sign that the blade has ever been in contact with the lag screw at all.The closer inspection of the set screw grooves at the blade has shown that there are no marks from the set screw visible.Typically, one of the grooves should show slight impression marks from the set screw tips.But there is in this case no indication that the set screw was inserted as required per operative technique before the u-blade was inserted.In this relation it must be pointed out that the placement of the set screw does ensure the correct position of the lag screw before the u-blade is inserted.A functional test with a nail was made, although the blade is deformed it could still be easily inserted into the grooves of the in the nail placed lag screw and the legs have widened at the front as intended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.No product related issue could be detected.Based on the performed investigation was most likely the lag screw not correctly aligned, and the u-blade did get stuck at the nail as the grooves were not in the correct position.In this relation following statement of the gamma4 hip fracture nailing system operative technique can be pointed out.For correct rc lag screw alignment, the handle of the lag screwdriver must be perpendicular to the proximal targeting arm.The u-blade laser markings at the set screw groove indicators must point towards caudal and cranial indicating the orientation of the u-blade in-situ.If more information is provided, the case will be reassessed.

• Brand Name: RC LAG SCREW GAMMA4 Ø10.5X90MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20052033
• Report Number: 0009610622-2024-00811
• Device Sequence Number: 18126203
• Product Code: HSB
• UDI-Device Identifier: 07613327591804
• UDI-Public: 07613327591804
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: Health Professional
• Device Catalogue Number: 81660090S
• Device Lot Number: K19891D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female