MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 3.3MM DRILL 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	2107-3325
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The following was reported: during the case, flex drill guide and drill were broken.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a trident drill bit was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the drill bit is fractured in the area of the flutes.The fractured tip was not returned.The flutes and upper portion of the shaft appear to be damaged as well.Material analysis: review of the device with a materials analysis engineer indicated that the drill bit fractured in overload.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the drill bit fractured during surgery.Visual inspection of the returned device indicated that the drill bit is fractured in the area of the flutes.The fractured tip was not returned.The flutes and upper portion of the shaft appear to be damaged as well.Review of the device with a materials analysis engineer indicated that the drill bit fractured in overload.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: during the case, flex drill guide and drill were broken.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a trident drill bit was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis and indicated the following: on visual examination, the fracture on the detachable flex shaft was observed approximately 3 mm from the drill chuck housing.The fracture was observed approximately 27 mm from the end of the drill bit." material analysis: a material analysis was performed and concluded the following: "review of the returned drill bit confirmed a fracture to the fluted tip of the drill bit.Characterisation using stereo microscopy and scanning electron microscopy confirmed the drill bit fractured due to overload.Mechanical damage was observed around the sides of the fluted region near the fracture surface.No manufacturing or material related defects were observed on the device surfaces examined." clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the drill bit fractured during surgery.Visual inspection of the returned device was performed as part of the material analysis and indicated the following: on visual examination, the fracture on the detachable flex shaft was observed approximately 3 mm from the drill chuck housing.The fracture was observed approximately 27 mm from the end of the drill bit." the material analysis concluded the following: "review of the returned drill bit confirmed a fracture to the fluted tip of the drill bit.Characterisation using stereo microscopy and scanning electron microscopy confirmed the drill bit fractured due to overload.Mechanical damage was observed around the sides of the fluted region near the fracture surface.No manufacturing or material related defects were observed on the device surfaces examined." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The following was reported: during the case, flex drill guide and drill were broken.

• Brand Name: 3.3MM DRILL 25MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12917842
• Report Number: 0002249697-2021-02012
• Device Sequence Number: 5644972
• Product Code: LPH
• UDI-Device Identifier: 07613327212358
• UDI-Public: 07613327212358
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K161569
• 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,Followup
• Report Date (Section B): 12/15/2022

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: 2107-3325
• Device Catalogue Number: 2107-3325
• Device Lot Number: SC26809D
• 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: 11/10/2021
• Supplement Date Received by Manufacturer: 07/26/2022; 12/07/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 08/22/2022; 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 85 KG