MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; SCREW, FIXATION, BONE

Catalog Number	2030-6530-1
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the event description, the event involved one screw going through the trident shell.Since the exact lot involved was not identified, the lot number has been reported as "unknown".One of the following lots were reportedly involved with this event: wk6xp3 or vm20k.Review of the device history records indicate devices were manufactured and accepted into final stock on with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.
Event or Problem Description
Placed a trident hemispherical acetabular cup and inserted a 6.5 torx bone screw and screw went through the cup.
Additional Manufacturer Narrative
According to the event description, the event involved one screw going through the trident shell.Since the exact lot involved was not identified, the lot number has been reported as "unknown".One of the following lots were reportedly involved with this event: wk6xp3 or vm20k.Lot code vm20k corrected to vm20kv.An event regarding a bone screw going through the trident shell and into the acetabulum was reported.The event was confirmed.Device evaluation and results: not performed as device remains implanted.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant noted the following; procedure-related factors: error in surgical positioning of torx bone screw used for supplemental screw fixation.Patient-related factors none device-related factors: none diagnosis: implantation of a torx bone screw intended for supplemental screw fixation with entry through a wrong cup screw hole outside the so-called ¿safe zone¿ and under a very steep angle caused the relatively sharp edge of the flat screw head to cut through the relatively soft titanium of the cup shell perforating same.No adverse consequences are to be expected now or in the future.A device history review confirmed all devices were manufactured and accepted into finished goods with no reported discrepancies.A complaint history review confirmed no similar events for the reported lot.A review of the provided x-rays by a clinical consultant concluded: implantation of a torx bone screw intended for supplemental screw fixation with entry through a wrong cup screw hole outside the so-called ¿safe zone¿ and under a very steep angle caused the relatively sharp edge of the flat screw head to cut through the relatively soft titanium of the cup shell perforating same.No adverse consequences are to be expected now or in the future.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
Event or Problem Description
Placed a trident hemispherical acetabular cup and inserted a 6.5 torx bone screw and screw went through the cup.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6786312
• Report Number: 0002249697-2017-02440
• Device Sequence Number: 13742495
• Product Code: HWC
• UDI-Device Identifier: 07613327037005
• UDI-Public: 07613327037005
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 2030-6530-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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
• Patient Age: 78 YR