MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 25MM; SCREW, FIXATION, BONE

Catalog Number	2030-6525-1
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2018
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 reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Primary procedure, right hip.Rep was present in the operating room.It was reported that a 25 mm screw was requested.Rep handed a box marked for a 25 mm screw to the nurse.The nurse took the inner packaging out, opened it, and handed the screw to the surgeon.Nurse verified that the inner packaging was marked for a 20 mm screw.By this time, the screw was inside the patient.Surgeon reported he had felt the screw was shorter than expected.No surgical delay was caused as the screw went directly into the patient, and surgeon reported satisfactory fixation and no patient harm due to the shorter screw.
Additional Manufacturer Narrative
An event regarding a product mix involving an cancellous bone screw 25mm was reported.The event was not confirmed.Conclusion: the investigation concluded the reported event could not be confirmed as no product was returned and the memo attached states that " as the two potentially affected lots in question from the complaint were manufactured approximately 3 months apart, the potential swap did not occur within the packaging cell.No other discrepanices were noted on the dhrs which would call into question the dates of manufacture.Thus, since it has been determined that the potential swap was not caused interally, no nc will be opened for this issue." no further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, right hip.Rep was present in the operating room.It was reported that a 25mm screw was requested.Rep handed a box marked for a 25mm screw to the nurse.The nurse took the inner packaging out, opened it, and handed the screw to the surgeon.Nurse verified that the inner packaging was marked for a 20mm screw.By this time, the screw was inside the patient.Surgeon reported he had felt the screw was shorter than expected.No surgical delay was caused as the screw went directly into the patient, and surgeon reported satisfactory fixation and no patient harm due to the shorter screw.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 25MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7309434
• Report Number: 0002249697-2018-00604
• Device Sequence Number: 11029580
• Product Code: HWC
• UDI-Device Identifier: 07613327036992
• UDI-Public: 07613327036992
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K894124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2018

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: 12/31/2022
• Device Catalogue Number: 2030-6525-1
• Device Lot Number: H92RL0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 05/18/2018
• 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: 82 YR