MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO SMALL GAMMA3 4.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-3042
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "in the procedure of the gamma nail, the bit of 4.2 is passed to block distal and at the moment of passing it the point is bending, when trying to pass it again, the point of the bit is splitted.".
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: the received drill shows signs of intense usage.The drill was found to be broken from the tip.The cutting edges of the drill are absolutely blunt and severe material deformation and damage can also be seen around it.The breakage surface reveals a relatively smooth surface and absence of any plastic deformation.This confirms a brittle fracture due to high torsional and bending load leading to a forced fracture.The red spots on the fracture surface was checked for rust.Upon testing it was confirmed that there was no rust or other oxidation, hence no material deficiency.The critical diameter of the drill was observed to be 4.18mm as required against a range of 4.10mm - 4.20mm.Similarly, the average hardness of the drill was observed to be 53.3 hrc as required against a range of 52.0 hrc ¿ 56.0 hrc.As per the dimensional inspection and hardness testing, the returned drill was found to be within specifications.However, the most important point to note is, a third-party engraving, supposedly for a rework/refurbishment was observed on the surface of the drill.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.Based on the investigation it was found that although there was failure confirmation; there was already a refurbishment done to the drill as indicated by the engraving on the external surface.This marking is not made by stryker at any point of time.Instruments which are refurbished by third parties/external sources and then returned to the customers are not regarded to have been put on the market by stryker.After any sort of rework has been performed externally, they become products of a third party.There are no warranty claims against stryker for third-party products.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "in the procedure of the gamma nail, the bit of 4.2 is passed to block distal and at the moment of passing it the point is bending, when trying to pass it again, the point of the bit is splitted.".

• Brand Name: DRILL, AO SMALL GAMMA3 4.2X300MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11168084
• Report Number: 0009610622-2021-00233
• Device Sequence Number: 11635140
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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 Model Number: 1320-3042
• Device Catalogue Number: 13203042
• Device Lot Number: KU96850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1