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	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported that: in the case, the acetabuluma screw broken during screwing.
Event or Problem Description
It was reported that: in the case, the acetabulum screw broken during screwing.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a trident drill bit was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device was fractured through the fluted section.The flutes appear in used condition.Material analysis: a material analysis was performed and indicated the following: "failure was from fast fracture mechanism common to high hardness, martensitic stainless steels.The fracture most likely initiated at a sharp edge and propagated quickly across the diameter without plastic deformation.The drill was made from the designated alloy and heat treated to a high hardness.No manufacturing defects were found on the surfaces inspected here." 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 broke during surgery.Visual inspection of the returned device indicated that the device was fractured through the fluted section.The flutes appear in used condition.A material analysis was performed and indicated the following: "failure was from fast fracture mechanism common to high hardness, martensitic stainless steels.The fracture most likely initiated at a sharp edge and propagated quickly across the diameter without plastic deformation.The drill was made from the designated alloy and heat treated to a high hardness.No manufacturing defects were found on the surfaces inspected here." 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.

• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11730573
• Report Number: 0002249697-2021-00737
• Device Sequence Number: 14280062
• 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: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: SC26809
• 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: 04/06/2021
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• 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 Sex: Unknown