MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LIMITED SYSTEM 26 K-WIRE FOR 4.0MM SCREW DRILL TIP 1.6X150MM; ORTHOPAEDIC BONE WIRE

Model Number	OS900026-NS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly during a talonavicular fusion procedure, two k-wire tips were identified to have broken off in the patient and retained.Potentially, the k-wires may have clashed with hardware.The k-wires are implant grade 316lvm stainless steel.
Additional Manufacturer Narrative
Review of the device history records confirmed that the product was supplied in conformance with ortho solutions specifications.None of the devices were returned, thus visual inspection was not undertaken.Based on the clinical information provided, it was identified that the k-wire breakage was likely attributed to the insertion of the wires in close proximity to an implanted screw, insertion without the aid of fluoroscopy is likely to have led to interference of the k-wire trajectory, causing a deflection of the wire and possibly resulting in breakage.It is also possible that the k-wire breakage occurred whilst drilling over the wire, as the deflection at the wire tip would cause an interference between the drill and wire.Thus, the root cause for the k-wire breakages is mostly attributed to use error in insertion of k-wires in the close proximity of an implanted screw without assisted imaging.K-wire fracture is an identified hazard in the risk management conducted for system 26.The root cause for the complaint is therefore due to interference with a previously implanted screw, as k-wire breakage is inevitable when subject to an interfering trajectory.The complaint does not suggest any new or emerging risks with the device when utilised in accordance to its intended use.The following conclusions were made: the root cause for the k-wire breakages is attributed to use error, via insertion of k-wires in the close proximity of an implanted screw without assisted imaging.Based on the clinical information and conformance evidenced by the dhrs, the complaint therefore does not suggest any emerging risks with the use of the device in its intended use.The issue is considered closed.However, should any new pertinent data be received, the investigation will be re-opened.
Event or Problem Description
Reportedly during a talonavicular fusion procedure, two k-wire tips were identified to have broken off in the patient and retained.Potentially, the k-wires may have clashed with hardware.The k-wires are implant grade 316lvm stainless steel.

• Brand Name: SYSTEM 26 K-WIRE FOR 4.0MM SCREW DRILL TIP 1.6X150MM
• Common Device Name: ORTHOPAEDIC BONE WIRE
• Manufacturer (Section D): ORTHO SOLUTIONS UK LIMITED; west station business park; spital road; maldon, essex, CM9 6 FF; UK CM9 6FF
• MDR Report Key: 9165611
• Report Number: 3008951116-2019-00005
• Device Sequence Number: 19535863
• Product Code: HTY
• UDI-Device Identifier: 05055662955996
• UDI-Public: 05055662955996
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: OS900026-NS
• Device Catalogue Number: OS900026-NS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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