MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE,SURGICAL

Model Number	292.16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth and weight not available for reporting.Additional product code: hty.(b)(4) lot number unknown.Device malfunctioned intra-operatively and was 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.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 an open reduction and internal fixation (orif) of the left distal humerus, part of the 1.6 mm k-wire used to hold the plate broke when the surgeon was trying to remove it after the fixation of the screws in the plate.The fragments generated were retained in the patient.The procedure was completed with no delay.The patient was stable after the surgery.Concomitant device reported: 2.7 mm/3.5 mm variable angle locking compression plate (va-lcp) extended medial distal humerus plate 4 hole left 111 mm long (part 02.117.704, lot number unknown, quantity 1), 2.7 mm/3.5 mm va-lcp lateral distal humerus plate 1 hole left 69 mm short (part 02.117.901, lot number unknown, quantity 1), 2.7 mm/3.5 mm va-lcp proximal olecranon plate 2 hole left 73 mm (part 02.107.102, lot number unknown, quantity 1), and screw (part number unknown, lot number unknown, quantity unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Common Device Name: WIRE,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7178126
• Report Number: 2939274-2018-50150
• Device Sequence Number: 13692156
• Product Code: LRN
• UDI-Device Identifier: 20886982180374
• UDI-Public: (01)20886982180374(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2017

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 Model Number: 292.16
• Device Catalogue Number: 292.16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR