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

Catalog Number	03.010.046
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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.Manufacturing location: (b)(6).Manufacturing date: december 11, 2015.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that during a lateral entry femoral reconstruction nail procedure, the surgeon backed the nail out a short distance by hitting the underside of the insertion handle with a mallet.The mallet damaged the hole that the locking sleeve goes through, making the hole distorted and unable to accept any other locking sleeves.The surgery was completed successfully by locking the nail in a different way.There were no fragments generated, no surgical delay reported, and no reported harm to the patient.The patient's outcome was stable following the surgery.Reported concomitant parts: lateral entry femoral recon nail (part unknown, lot unknown, quantity 1); locking sleeve (part unknown, lot unknown, quantity 1); mallet (part unknown, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.It was reported that during a lateral entry femoral reconstruction nail procedure, the surgeon backed the nail out a short distance by hitting the underside of the insertion handle with a mallet.The mallet damaged the hole that the locking sleeve goes through, making the hole distorted, and unable to accept any other locking sleeves.The surgery was completed successfully by locking the nail in a different way.There were no fragments generated, no surgical delay, no reported harm to the patient.The patient's outcome was stable following the surgery.Following device was returned for cq investigation; percutaneous insertion handle part #03.010.046, synthes lot# 9598388.The returned instruments was examined at customer quality and the complaint condition was confirmed.A visual inspection, device history records review and dimensional drawing review were performed as part of this investigation.No new malfunctions were identified during the investigation.The percutaneous insertion handle (p/n 03.010.046) that was returned has indentation marks on the underside of the main handle body.There is a dent on the distal opening of the hole that accommodates protection sleeve (p/n 03.010.046) for facilitate locking screw insertion.This damage is interfering with the functionality of the insertion handle and stopping protection sleeve to slid thru it and sit at the desired position.The complaint condition was replicated using protection sleeve (p/n 03.010.063, lot# 9598388) available at cq location.The protection sleeve was not able to be fully inserted in the damaged entry hole of the insertion handle and got stuck midway.The rest of the surface/features of the insertion handle show no signs of damage and minimal surface wear and are in functional condition.Relevant product drawings were reviewed: top level drawings percutaneous insertion handle were reviewed.Per sheet 1 of the above drawing, distal end of the datum d is damaged.Id of this feature was using calibrated gauge pins entered thru proximal hole.The id was found to be within specification, measuring at 12.02 mm using gauge pin (spec: 12 +0.036 ).The design, materials and finishing processes were found to be appropriate for the intended use of these devices.As the complaint describes, the distal end of the feature that accommodates entry of protection sleeve was damaged during operation due to hammering.This is a case of improper technique and/or product abuse.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 INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6689189
• Report Number: 3003875359-2017-10323
• Device Sequence Number: 72482
• Product Code: LXH
• UDI-Device Identifier: 10886982067180
• UDI-Public: (01)10886982067180(10)9598388
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 06/08/2017

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: 9598388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 07/14/2017; 07/21/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 07/19/2017; 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 UNKNOWN LATERAL ENTRY FEMORAL RECON NAIL.; 1 UNKNOWN LOCKING SLEEVE.; 1 UNKNOWN MALLET.
• Patient Age: 24 YR
• Patient Weight: 86