MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T10 FULL THREAD, 2.7MM/L28MM; SCREW, FIXATION, BONE

Catalog Number	657128
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device disposition unknown.
Event or Problem Description
It was reported through a medwatch (mw5085445) "a female who is status post spanning external fixation for an open intra-articular left distal tibia fracture.She presents back to the operating room today.At this point we turned out attention to the medial wound and packed the lateral wound open.The medial wound was reopened and extended proximally approx.6 cm for a long comminuted medial spike.With the skin open, the subcutaneous fat was divided longitudinally and the posterior medial corner of the tibia was identified and exposed.The fracture was noted to be comminuted on the medial side with 2 main fracture fragments, one with a large anteromedial butterfly fragment and a large posterior central fragment.They were mobilized curetted, impaired and the reduced with 2 lobster claw with k-wires.At this point a 10-hole 2.7 mm plate from stryker was the fashion on the posterior medial cortex of the tibia, and was fixed proximally with 3 screws and no screws in the distal fragment to not block our reduction and manipulation on the lateral side.Our reduction showed our alignment in the sagittal and coronal plane to be excellent on the medial side.We turned our attention back to the lateral side and an anterolateral stryker plate of appropriate length distal to our external fixation was then passed in a submuscular fashion along the anterolateral aspect of the shaft and k-wired into position.It was fixed first distally with 2 nonlocking screws and then 2 locking screws distally.One add'l locking screw was placed.At this point, the plate was fixed to the shaft through the open wound and proximally with a 3.5 mm cortical screw and then 2 screws proximally percutaneously.We had excellent fixation on the lateral side.I should note that one of the 2.7 mm screws from medial to lateral had been loosened to facilitate the plate manipulation.Upon re-tightening the middle of the three, the head broke off.The body of the screw remained encased in the tibia and was only minimally visible underneath the plate.After assessing intraoperative imaging that showed that the remainder of the screw appeared to be intact and well encased in bone.I made the decision to leave the screw in the bone and not remove the plate, lose our reduction, and potentially risk malreduction or add'l surgical time for infection.The screw was clearly not adjacent to or abutting neurovascular structures and again, was well encased in bone.".

• Brand Name: BONE SCREW, T10 FULL THREAD, 2.7MM/L28MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8579695
• Report Number: 0008031020-2019-00384
• Device Sequence Number: 11172494
• Product Code: HWC
• UDI-Device Identifier: 07613327069594
• UDI-Public: 07613327069594
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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: 657128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62
• Patient Weight: 99