MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH AIM-ARM F/VA-LCP CONDYLAR PL 4.5/5.0 R; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number	03.231.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.No patient information reported.Additional product codes hwc, hrs.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.No phone number or city available for reporter.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Report from device synthes europe reports an event in the (b)(6) as follows: it was reported that the instrument tray was opened for a case.During assembly of the necessary devices, the scrub nurse accidentally attached the aiming arm incorrectly thus causing the instrument to be unusable.The aiming arm and the bolt broke during the intraoperative assembly.All fragments were removed from the patient.The team reverted to using their back up system to complete the procedure.A 40 minute surgical delay was reported.No patient harm reported.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part: 03.231.004, lot: 9405984: manufacturing site: haegendorf, release to warehouse date: 22.Apr.2015: no non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: a product investigation was performed.The evaluation has shown that the coupling bolt of the aiming arm is completely seized in the locking bolt.It looks like the coupling bolt was screwed into the locking bolt till the end/run-out of the locking bolt thread was reached and then was tightened into the thread run-out which finally caused the seizing.No breakage could be detected at the received devices.The slot of the positioning bolt of the aiming arm is damaged, most likely caused by forcible disassembling attempts.The root cause of this occurrence is use related, as illustrated in the va-lcp condylar plate 4.5/5.0 surgical technique is the aiming arm attached to the slotted part of the insertion handle and not to the locking bolt.The locking bolt is only used to attach the insertion handle to the plate and not to fix the aiming arm.This use error is also confirmed in the complaint description, where is it mentioned that the aiming arm accidentally attached incorrectly.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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.

• Brand Name: AIM-ARM F/VA-LCP CONDYLAR PL 4.5/5.0 R
• Common Device Name: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7412313
• Report Number: 8030965-2018-52936
• Device Sequence Number: 1482222
• Product Code: JDP
• UDI-Device Identifier: 07611819454415
• UDI-Public: (01)07611819454415(10)9405984
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: 03.231.004
• Device Lot Number: 9405984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1