MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO SMALL GAMMA3 Ø4.2 X 300 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13203042S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
As reported: "when doing a short nail we use the 180mm nail most every time.We had a first scrub that had never used the system and therefore we help have everything ready prior to the start of the case including the 180 target sleeve on the introducer.Dr used a 170 nail and not the 180 like was planned.The nail was placed but because of the different lengths when drilling for the distal looking screw we hit the nail because prior to the case we set up for our standard 180 nail.Broke the drill bit traded the sleeve and opened a new drill bit." all debris was removed and disposed of.
Additional Manufacturer Narrative
Please note the correction to d4 gtin.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.Based on the provided information, the root cause was attributed to a user related issue.The event was caused by the accidental use of a speedlock sleeve 180 in combination with a 170mm nail during the procedure.In this relation also the per gamma3 hip fracture nailing system operative technique (g3-st-13, 03-2021) required pre-testing can be mentioned as by this test the deviation would have been detected prior to the nail insertion: «prior to nail insertion, the implant and instrument assembly must be checked.Ensure that the sleeve angle matches the corresponding nail angle chosen, e.G.A 125° position in speedlock sleeve for a 125° nail, and the distal sleeve matches either for «dynamic» or «static» locking as required.» if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when doing a short nail we use the 180mm nail most every time.We had a first scrub that had never used the system and therefore we help have everything ready prior to the start of the case including the 180 target sleeve on the introducer.Dr used a 170 nail and not the 180 like was planned.The nail was placed but because of the different lengths when drilling for the distal looking screw we hit the nail because prior to the case we set up for our standard 180 nail.Broke the drill bit traded the sleeve and opened a new drill bit." all debris was removed and disposed of.

• Brand Name: DRILL, AO SMALL GAMMA3 Ø4.2 X 300 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20775407
• Report Number: 0009610622-2024-00927
• Device Sequence Number: 4413073
• Product Code: LXH
• UDI-Device Identifier: 04546540377890
• UDI-Public: (01)04546540377890(17)280229(11)K127BF4
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 01/15/2025

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: 13203042S
• Device Lot Number: K127BF4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2023
• 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
• Patient Sex: Unknown