MAUDE Adverse Event Report: SYNTHES HAGENDORF AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX; GUIDE

Catalog Number	03.010.052
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part number 03.010.052 and lot number 1449466.Manufacturing location: (b)(4).Manufacturing date: 16.Feb.2006.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 on 14-sep-2017, during an open reduction internal fixation (orif) of a tibia, the trocar was targeted to the anteroposterior (ap) hole on the nail.The hole on the aiming arm did not allow the trocar to pass through it.Another hole on the aiming arm was selected and three (3) proximal screws were inserted successfully.No issues were found with the trocar assembly.There was no surgical delay and the patient was reported to be in stable condition.This complaint is for one (1) device.Concomitant devices reported: unknown outer drill sleeve (unknown part number, unknown lot number, quantity 1), unknown trocar(unknown part number, unknown lot number, quantity 1); unknown protection sleeve (unknown part number, unknown lot number, quantity 1); unknown locking screw (unknown part number, unknown lot number, quantity 1); unknown insertion handle (unknown part number, unknown lot number, quantity 1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device (aiming arm for ti cannulated tibial nails-ex, part number 03.010.052, lot number 1449466).The subject device was returned with the complaint condition stating: upon receipt damage was noted on the distal side of the anteroposterior hole.This complaint is confirmed.A visual inspection, dimensional analysis, drawing and device history record review were performed as part of this investigation.A visual inspection revealed a dent on the distal side of the anteroposterior hole.The drawing showed that the hole should be between 12 and 12.036 mm.The dimensional analysis measured the distal side to be 11.97 mm (gp32) while the proximal side remained at 12.00 mm (gp29).This complaint in confirmed.Upper level drawing 03_010_052 and 03_010_052_1 were reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.Material and hardness testing is not applicable at this time as they were tested at the time of manufactured and confirmed to have no issues through the dhr review.No definitive root cause could not be determined as the circumstances surrounding the complaint are unknown; however, a possible cause is that the post manufacturing damage occurred during sterile processing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6911330
• Report Number: 3003875359-2017-10484
• Device Sequence Number: 10794198
• Product Code: FZX
• UDI-Device Identifier: 10886982067241
• UDI-Public: (01)10886982067241(10)1449466
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

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 Catalogue Number: 03.010.052
• Device Lot Number: 1449466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 59