MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACETABULAR REAMER HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2102-0410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
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.Device not returned.
Event or Problem Description
Customer informed to customer service assistant via phone that reamer hand piece was broken off to inside the attachment.The event didn't cause any harm for the patient or personnel or any surgical delay.Customer took a new item for replace.
Additional Manufacturer Narrative
An event regarding fracture & wear involving a cutting edge reamer was reported.Conclusions: the device was shipped to the supplier, (b)(4), for evaluation.The supplier confirmed the event.See the attached report from the supplier for details.The damaged device was discovered during inspection.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.
Event or Problem Description
Customer informed to customer service assistant via phone that reamer hand piece was broken off to inside the attachment.The event didn't cause any harm for the patient or personnel or any surgical delay.Customer took a new item for replace.

• Brand Name: ACETABULAR REAMER HANDLE
• 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: 8703426
• Report Number: 0002249697-2019-02263
• Device Sequence Number: 11280874
• Product Code: LPH
• UDI-Device Identifier: 07613327211825
• UDI-Public: 07613327211825
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 03/31/2019
• Device Catalogue Number: 2102-0410
• Device Lot Number: 2644934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other