MAUDE Adverse Event Report: SYNTHES HAGENDORF SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.010.084
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Date of event: unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part # 03.010.084, lot #1415183: manufacturing location: (b)(6), manufacturing date: 17.Nov.2005: no non conformance reports (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.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 spin piece of the spiral blade inserter for retrograde femoral nails-ex device broke off cleanly from the back end of the device.That broken piece is missing and cannot be found.This device was discovered in the centralized processing department.This may have occurred during the cleaning process in the centralized processing department.There were no other fragmented pieces.There was no patient involvement.This report is for one (1) spiral blade inserter for retrograde femoral nails-ex.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed.A visual inspection, dhr review, and drawing review were performed as part of this investigation.The device (part #: 03.010.084, lot #: 1415183, qty 1) was returned to customer quality (cq) for investigation.The device was returned missing the inserter top.The hand grip easily slides off the spiral blade inserter body.This device is not broken as this involves finished goods falling apart/missing components.This complaint is confirmed.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the instrument is already missing components.Dimensional testing is not applicable due to the failure being related to the missing component.Functional testing is not applicable due to the missing component.Relevant drawings were reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.No definitive root cause could be determined.However, based on the complaint, the component was most likely lost during sterile processing.Device is approx 12 years old.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: SPIRAL BLADE INSERTER FOR RETROGRADE FEMORAL NAILS-EX
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6880596
• Report Number: 3003875359-2017-10469
• Device Sequence Number: 16285409
• Product Code: LXH
• UDI-Device Identifier: 10886982067548
• UDI-Public: (01)10886982067548(10)1415183
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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: 03.010.084
• Device Lot Number: 1415183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Initial Date Received by Manufacturer: 08/29/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1