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

Catalog Number	03.010.046
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Dhr review for 03.010.046, lot 3432486.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.Manufacturing location: (b)(6).Manufacturing date: june 01, 2010.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 the insertion handle broke during a lateral entry femoral nailing procedure on (b)(6) 2017.The surgeon had performed the procedure per the technique guide but did not like the way the nail was seated in the femur and opted to remove it despite no allegation of deficiency or malfunction against the nail.The surgeon opted to remove the nail and wanted to ¿start over¿ with a new nail.During the removal of the nail, the approximate 1mm x 1mm tab that keeps the nail from rotating on the handle broke off and was lost in the patient¿s bone.Surgeon decided not to remove the fragment.The nail was removed intact with no allegation of deficiency/malfunction and was then discarded.The surgeon then re-reamed the bone using a different technique and inserted a new nail of the same size without difficulty.There was no reported surgical delay and no additional x-rays were required.It is noted that this was a difficult case but was performed in accordance with the technique guide.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: femoral nail (part number unknown, lot number unknown, quantity 1); mallet (part number unknown, lot number unknown, quantity 1); connecting screw (part number unknown, lot number unknown, quantity 1); driving cap (part number unknown, lot number unknown, quantity 1).This report is for one (1) percutaneous insertion handle.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: this complaint is confirmed.The distal alignment tab has sheared off at its base and was not returned.Whether this complaint can be replicated is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.The returned percutaneous insertion handle is a reusable instrument available for use in the titanium cannulated lateral entry femoral recon nail instrument set 01.003.300 which is part of the expert nailing system.Instructions for use can be found in technique guide.A visual inspection under 5x magnification, device history record (dhr) review, complaint history review, drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Dimensional inspection of feature(s) relevant to this complaint (tab thickness, width, length) could not be obtained on the returned part because the tab sheared off at its base and was not returned.No non-conformance reports 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.The relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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 INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6752159
• Report Number: 3003875359-2017-10369
• Device Sequence Number: 13685967
• Product Code: LXH
• UDI-Device Identifier: 10886982067180
• UDI-Public: (01)10886982067180(10)3432486
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.046
• Device Lot Number: 3432486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 07/02/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR