MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BODY/STEM SEPARATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6278-9-070
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
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.When completed, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
The surgeon went to put in the cone body for a restoration modular.When he impacted it the white handle cracked on the cone body inserter.Then he needed to change his version so he used the body stem separator.While he used it he was able to get it to work, but the piece looked bent and he asked it be replaced.
Additional Manufacturer Narrative
An event regarding damage involving a restoration modular separator was reported.The event was confirmed through visual inspection.Method & results: device evaluation and results: visual inspection: examination of the returned device with engineer indicated that the device is damaged due to in service use.Medical records received and evaluation: 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 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
The surgeon went to put in the cone body for a restoration modular.When he impacted it the white handle cracked on the cone body inserter.Then he needed to change his version so he used the body stem separator.While he used it he was able to get it to work, but the piece looked bent and he asked it be replaced.

• Brand Name: BODY/STEM SEPARATOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7969690
• Report Number: 0002249697-2018-03377
• Device Sequence Number: 1739611
• Product Code: LXH
• UDI-Device Identifier: 07613327221626
• UDI-Public: 07613327221626
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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 Catalogue Number: 6278-9-070
• Device Lot Number: TACF81E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/08/2019
• 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