MAUDE Adverse Event Report: STRYKER GMBH K-WIRE, FULLY THREADED, 1.6MMX200MM; PLATE, FIXATION, BONE

Catalog Number	45-80100
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "k-wire was driven in to bone with stryker cd8 cordless driver and wire collet (facility owned).The k-wire broke off in the fibula.Case was an orif right fibula.The k-wire was barely protruding posterior and medial in the fibula.The capital fragment of the wire was removed but broken tip was stuck in the bone and unable to be removed easily.Tip protruding was too short to grip with the wire collet and further complicated by its position being difficult to access.Surgeon attempted to cut the tip to no avail.Surgeon attempted to bend the wire up and into the bone to prevent soft tissue irritation to no avail.Wire was ultimately removed by making multiple holes in the bone with a k-wire adjacent to the wire to loosen and free it to the point where it could be gripped and pulled free." delay in surgery and multiple holes made in the bone with another k-wire.Surgical delay of 30-40 minutes.
Additional Manufacturer Narrative
The reported event that k-wire, smooth, 1.4mmx100mm was alleged of issue s-11 (breakage during surgery) could not be confirmed, since the device returned for evaluation did not match the alleged failure mode.The product was returned for evaluation; however, during visual inspection, it was found to be in perfect condition.Both ends of the product was found to be in good condition.Considering the nature of the returned product and the alleged complaint, functional and dimensional inspection was not considered necessary.The device history record could not be reviewed as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "k-wire was driven in to bone with stryker cd8 cordless driver and wire collet (facility owned).The k-wire broke off in the fibula.Case was an orif right fibula.The k-wire was barely protruding posterior and medial in the fibula.The capital fragment of the wire was removed but broken tip was stuck in the bone and unable to be removed easily.Tip protruding was too short to grip with the wire collet and further complicated by its position being difficult to access.Surgeon attempted to cut the tip to no avail.Surgeon attempted to bend the wire up and into the bone to prevent soft tissue irritation to no avail.Wire was ultimately removed by making multiple holes in the bone with a k-wire adjacent to the wire to loosen and free it to the point where it could be gripped and pulled free." delay in surgery and multiple holes made in the bone with another k-wire.Surgical delay of 30-40 minutes.

• Brand Name: K-WIRE, FULLY THREADED, 1.6MMX200MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7069140
• Report Number: 0008010177-2017-00290
• Device Sequence Number: 1798906
• Product Code: HRS
• UDI-Device Identifier: 07613154628902
• UDI-Public: 07613154628902
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 45-80100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2018
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 05/22/2018
• 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: Required Intervention
• Patient Age: 17 YR