MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 45MM; SCREW, FIXATION, BONE

Catalog Number	2030-6545-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that while the surgeon was attempting to tighten the screw, the screw head sheared off the shaft of the screw.It was reported that a surgical delay of 1 hour was noted while the surgeon attempted to remove the shaft.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an other hip screw was reported.The event was confirmed through visual inspection of the returned product.Method & results: -product evaluation and results: visual inspection of the returned product showed the screw was returned fractured.Damage is also observed on the threads of the screw.A review of the returned device by a material analysis engineer indicated: post fracture damages observed on fracture surface, obscuring the fracture surface.Damage consistent with contact against a hard object and the explantation process were also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-product history review: not performed as no lot information was provided.-complaint history review: not performed as no lot information was provided.Conclusion: visual inspection of the returned product showed the screw was returned fractured.Damage is also observed on the threads of the screw.A review of the returned device by a material analysis engineer indicated: post fracture damages observed on fracture surface, obscuring the fracture surface.Damage consistent with contact against a hard object and the explantation process were also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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
It was reported that while the surgeon was attempting to tighten the screw, the screw head sheared off the shaft of the screw.It was reported that a surgical delay of 1 hour was noted while the surgeon attempted to remove the shaft.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 45MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8338963
• Report Number: 0002249697-2019-01050
• Device Sequence Number: 16591664
• Product Code: HWC
• UDI-Device Identifier: 07613327037036
• UDI-Public: 07613327037036
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K894124
• 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): 04/24/2019

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: 2030-6545-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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