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

Catalog Number	6278-9-070
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Dr.Could not get the t handle on the rest mod cone body removal tool.Dr.Discovered that the top where it snaps into the handle was damaged and did not allow the handle to snap in.
Additional Manufacturer Narrative
An event regarding assembly issues involving a restoration modular separator was reported.The event was not confirmed.Method & results: -device evaluation and results: the returned devices consisted of the jackscrew and the puller were found to have scratches indicative of heavy use throughout the surfaces.The proximal tip of the puller showed damage.A functional inspection was performed with the returned jackscrew and puller and a t-handle (cat 6278-9-090, lot taxx508) from finished goods.The returned jackscrew was inserted to the returned puller and assembled with the t-handle with no difficulty by lifting the collar and hearing an audible click to ensure proper engagement.See the attached pictures.-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 reported event could not be confirmed.A visual inspection of the returned device shows in-service use.However, the returned device is found to be functionally acceptable when mated with a referenced instrument from finished goods.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Dr.Could not get the t handle on the rest mod cone body removal tool.Dr.Discovered that the top where it snaps into the handle was damaged and did not allow the handle to snap in.

• 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: 8629247
• Report Number: 0002249697-2019-02035
• Device Sequence Number: 2257971
• 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): 06/26/2019

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: 08/31/2023
• Device Catalogue Number: 6278-9-070
• Device Lot Number: TDEX500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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