MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL LATERJET CORACOID K-WIRE, 150 MM (SHORT); BONENAIL GUIDEWIRE

Catalog Number	285260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.(b)(4).The lot number is currently unavailable.
Event or Problem Description
It was reported by the sales rep reported that during an open shoulder repair, it was observed that the laterjet coracoid k-wire, 150 mm broke when the surgeon was drilling with it.The sales rep reported that the device broke in half outside of the patient and nothing fell inside the patient's joint space.The surgeon completed the procedure with another like device with no patient consequences.There was a 15 minute delay in the case.The sales rep could not provide the lot number or age of the device.The customer already discarded the complaint device.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: LATERJET CORACOID K-WIRE, 150 MM (SHORT)
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 2400 ; SZ 2400
• MDR Report Key: 7722308
• Report Number: 1221934-2018-52550
• Device Sequence Number: 16532509
• Product Code: LXH
• UDI-Device Identifier: 10886705017980
• UDI-Public: 10886705017980
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2014

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: 285260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2014
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1