MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.6MM COMPRESSION WIRE 25MM THREAD/150MM LENGTH; INSTRUMENT COMPRESSION

Catalog Number	03.211.425
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier reported only as (b)(6).Patient age, date of birth, and weight not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during a metatarsal-phalangeal joint (mtp) arthrodesis on (b)(6) 2018, one (1) out of three (3) compression wires snapped above its ball tip upon insertion, leaving its distal threaded portion and ball tip attached, and still implanted in the patient.A standard unknown wire driver was used to insert the wire.Using unknown pliers around the ball component of the implanted wire portion, the surgeon attempted to unscrew the wire.The ball component snapped from the threaded portion of the wire, leaving only the threaded portion implanted in the patient.The wire has a trocar tip.There were no tools available to remove the wire and no adequate removal tools owned by the hospital.Surgeon used a small hollow reamer and unknown extraction piece from a screw removal set to remove the wire.Removal was successful and there were no apparent detrimental outcomes.The procedure was successfully completed with a 30-45 minute surgical delay.There was no adverse event to patient and the patient's condition was stable post surgery.Concomitant devices reported: pliers (part number unknown, lot number unknown, quantity 1), wire driver (part number unknown, lot number unknown, quantity 1), va locking compression plate (lcp) first mtp fusion plate (part 02.211.237, lot number unknown, quantity 1).

• Brand Name: 1.6MM COMPRESSION WIRE 25MM THREAD/150MM LENGTH
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7883196
• Report Number: 8030965-2018-56402
• Device Sequence Number: 13930286
• Product Code: HWN
• UDI-Device Identifier: 10886982076342
• UDI-Public: (01)10886982076342
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: 03.211.425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/17/2018
• 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