MAUDE Adverse Event Report: STRYKER GMBH G4 PROX.TARGETING ARM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14200100
Medical Device Problem Codes	Break (1069); Crack (1135); Fracture (1260); Failure to Align (2522)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the targeting arm the lag screw reamer missed the nail and broke.The surgeon was really wrenching on the arm trying to get the reamer to pass, which might have led to a crack in the targeter.According to additional information received the "surgeon opened 2nd reamer that continued to miss the nail - something was off the with the targeting arm.The surgeon hammered the reamer in, to proceed with the case.Surgeon was able to get the wider part of the reamer in.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that during use of the targeting arm the lag screw reamer missed the nail and broke.The surgeon was really wrenching on the arm trying to get the reamer to pass, which might have led to a crack in the targeter.According to additional information received the "surgeon opened 2nd reamer that continued to miss the nail - something was off the with the targeting arm.The surgeon hammered the reamer in, to proceed with the case.Surgeon was able to get the wider part of the reamer in.".
Additional Manufacturer Narrative
Please note that the device code grid (f10 / h6 medical device problem code) was corrected (from "crack" to "break" / "fracture").Lot code / d4 was corrected.The reported event could not be confirmed, since the device was returned in separated condition.No other evidence was provided.Thus, targeting accuracy could not be verified.A review of the inspection records 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.The device inspection revealed the following: the g4 prox.Targeting arm was returned in 2 pieces.The handle had broken at the 1st connection pin in the transition from upper component with metal part and lower component with drill holes.In the case presented it was alleged ¿¿ the lag screw reamer missed the nail and broke.The surgeon at that time was really wrenching on the arm trying to get the reamer to pass, so there could have been a crack made at that time.¿ functional check is required prior to surgery.If performed successfully, a targeting deficiency can only be caused by inadequate handling.Based on investigation, the root cause was attributed to a user related issue.With given information a product deficiency could not be verified.

• Brand Name: G4 PROX.TARGETING ARM
• 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: 18793224
• Report Number: 0009610622-2024-00087
• Device Sequence Number: 18096338
• Product Code: HSB
• UDI-Device Identifier: 07613327479904
• UDI-Public: 07613327479904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 14200100
• Device Lot Number: KP483413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown