MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 3.3MM DRILL 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2107-3340
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2019
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
It was reported that " during robotic total hip surgery, the product was broken while screwing after the doctor put the acetabular cup.Pieces were removed by doctor.After washing, the doctor examined possibility of broken pieces on the patient by sight.".
Additional Manufacturer Narrative
Correction: no expiration date as this is a reusable instrument h5 and h8 have been updated accordingly.An event regarding crack/fracture involving a trident drill was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all 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 reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
It was reported that " during robotic total hip surgery, the product was broken while screwing after the doctor put the acetabular cup.Pieces were removed by doctor.After washing, the doctor examined possibility of broken pieces on the patient by sight." update: all broken parts has collected, pre-washed, packaged, sterilized and delivered to medical quality unit with complaint form.Both devices fractured.

• Brand Name: 3.3MM DRILL 40MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8616965
• Report Number: 0002249697-2019-01965
• Device Sequence Number: 11273278
• Product Code: LPH
• UDI-Device Identifier: 07613327212525
• UDI-Public: 07613327212525
• Combination Product (Y/N): N
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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 Expiration Date: 04/30/2016
• Device Catalogue Number: 2107-3340
• Device Lot Number: SC17322MD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1