MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L20MM; SCREW, FIXATION, BONE

Catalog Number 656320

Device Problems Break (1069); Degraded (1153)

Patient Problems Failure of Implant (1924); Injury (2348); Non-union Bone Fracture (2369); No Information (3190)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition is unknown.

Event Description

It was reported that the patient's left foot was revised due to a broken screw.Possible cause reported as patient weight bearing too early.Intra operatively, little pieces of metal were found in the patient.The plate was inspected and had no visible damage.The threading of the screws was visibly degraded.Patient was revised to competitor devices.Rep reported that no further information will be released by the hospital or surgeon.

Event Description

It was reported that the patient's left foot was revised due to a broken screw.Possible cause reported as patient weight bearing too early.Intra operatively, little pieces of metal were found in the patient.The plate was inspected and had no visible damage.The threading of the screws was visibly degraded.Patient was revised to competitor devices.Rep reported that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

The reported event could not be confirmed.Device evaluation: the reported device was returned and inspected with the following results listed below: visual inspection: reveals no significant damage to standard screw thread line.Superficial scratch marks observed on several parts of screw.As reported in the initial event details, ¿the threading of the screws was visibly degraded.¿.This could not be confirmed based on results of returned device inspection.This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be updated.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L20MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9179750
• MDR Text Key: 173179610
• Report Number: 0008031020-2019-01415
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K180500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 656320
• Device Lot Number: 1000332638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention