MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS; GUIDE

Catalog Number	357.366
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.It is unknown when device broke.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unavailable.Reporter is a synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
(b)(6) reports that on an unknown date, the two (2) rivets from the gold piece of the aiming arm broke off and as a result, the gold piece was loose.The issue was observed during cleaning of the device.There was no patient involvement.This report is for a 130 degree aiming arm for trochanteric fixation nails.This is report 1 of 1 for (b)(4).

• Brand Name: 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7854970
• Report Number: 2939274-2018-53657
• Device Sequence Number: 1271892
• Product Code: FZX
• UDI-Device Identifier: 10886982196019
• UDI-Public: (01)10886982196019
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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: 357.366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1