MAUDE Adverse Event Report: SYNTHES HAGENDORF PERCUTANEOUS INSERTION HANDLE; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number	03.010.046
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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: lot: l354620 part: 03.010.046 manufacturing location: (b)(4) manufacturing date: 27.Jun.2017 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 multiple instruments malfunctioned during a lateral entry femoral nailing to repair a midshaft femur fracture due to a motor vehicle accident on (b)(6) 2017.After the surgeon inserted the nail, he inserted the three-part trocar assembly, he then checked to make sure it was being targeted correctly.When he went to insert the guide wire, it kept hitting the nail and was misaligned.The misalignment issue only happened with one guide wire and first set of the three-part trocar assembly.Later in the procedure, he attempted to take the nail out, but the hammer kept getting jammed and wouldn¿t rock back and forth on the hammer guide, he struggled to get the nail out.Then, as the depth gauge was being used to measure the length of the recon screws; the surgeon tried three times and the measurement was inaccurate, it was 10mm longer than needed.There was a reported surgical delay of 10 minutes to take the nail out and reposition it.No additional x-rays or other medical intervention required.The procedure was completed successfully with the patient in stable condition.This complaint involves nine (5) devices.Concomitant devices reported: hammer guide (part# unknown, lot# unknown, quantity 1), nail (part# unknown, lot# unknown, quantity 1), extraction screw (part# unknown, lot# unknown, quantity 1).This report is 2 of 5 for (b)(4).
Additional Manufacturer Narrative
The percutaneous insertion handle (part #: 03.010.046, lot #: l354620) was reported as misaligned.The returned device was investigated and this complaint is unconfirmed.A visual inspection under 5x magnification, functional test, and drawing review were performed.Device was received showing minor wear but nothing that would inhibit functionality.A function test revealed the insertion handle mated as expected with the returned connecting screw and aiming arm.The nail was not returned so alignment to the nail could not be replicated.A dimensional inspection was not performed as the device connected as expected with other returned devices.Insertion handle drawing was reviewed during this investigation.No product design issues or discrepancies were observed.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: PERCUTANEOUS INSERTION HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 7035653
• Report Number: 3003875359-2017-10562
• Device Sequence Number: 11298850
• Product Code: LXH
• UDI-Device Identifier: 10886982067180
• UDI-Public: (01)10886982067180(10)L354620
• 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): 10/23/2017

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: 03.010.046
• Device Lot Number: L354620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR