MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO, STERILE T2 Ø4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18064260S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported : ''18-year-old patient admitted to the emergency room following a high-kinetic"avp" from his scooter without a helmet.During the operation, a t2 femoral nail was inserted using a nail-holder from a die thrower, which malfunctioned when the drill bit was inserted in order to fit the proximal synchro list.This was not in front of the hole.When inserting the nail, the nail-holder shifted.After several attempts at insertion, the bit broke.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual inspection of the drill bit indicates that the device is broken into two fragments from the tip of the drill.Broken surface shows minor chevron lines with relatively smooth surface without any plastic deformation which indicates towards a brittle failure of the drill due to mechanical overload leading to sudden breakage.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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 investigation, the root cause was attributed to a user related issue.The event was caused by a mechanical overload during drilling.However, a recurring nc was opened previously for such kind of issues in which no nonconformance related to product was found and it was closed without any further actions.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported : ''18-year-old patient admitted to the emergency room following a high-kinetic"avp" from his scooter without a helmet.During the operation, a t2 femoral nail was inserted using a nail-holder from a die thrower, which malfunctioned when the drill bit was inserted in order to fit the proximal synchro list.This was not in front of the hole.When inserting the nail, the nail-holder shifted.After several attempts at insertion, the bit broke.".

• Brand Name: DRILL, AO, STERILE T2 Ø4,2X340 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; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19961608
• Report Number: 0009610622-2024-00785
• Device Sequence Number: 7064355
• Product Code: LXH
• UDI-Device Identifier: 04546540196774
• UDI-Public: (01)04546540196774(11)240412(17)290331(10)K1B369A
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 18064260S
• Device Lot Number: KU175282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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 Age: 18 YR
• Patient Sex: Unknown