MAUDE Adverse Event Report: SYNTHES HAGENDORF 14.0MM CANNULATED AWL

Catalog Number	03.010.041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: device was used for treatment, not diagnosis.No patient involvement.It is unknown when breakage occurred.Device is an instrument and is not implanted/explanted.A review of the device history records has been completed.Manufacturing location: (b)(4), manufacturing date: august 28, 2006.No non-conformance records 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.Subject device has been received and is currently in the evaluation process.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 an awl was discovered broken in a storage warehouse outside of hospital.No patient involvement was reported.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was performed on the returned subject device (14.0mm cannulated awl, part # 03.010.041, lot # 1544254).The complaint condition is confirmed as the awl was received with a small semi-circular portion, approximately 2.5mm across and 1.5mm deep, broken from the distal tip of the device.The broken portion was not received.A device history record (dhr) review, visual inspection, and drawing review were performed as part of this investigation.The returned part was determined to be suitable for the intended use when employed as recommended.The returned awl (03.010.041) is included in a variety of trauma nail sets, including the titanium cannulated retrograde/antegrade femoral nail (rafn), titanium cannulated adolescent lateral entry femoral nail, and the titanium cannulated lateral entry femoral recon nail systems.The technique guide for the titanium cannulated rafn states that the awl (03.010.041) is used over a guide wire and is an alternative instrument designed to manually open the medullary canal for 9.0mm to 13.0mm nails.The awl was received with a small semi-circular portion, approximately 2.5mm across and 1.5mm deep, broken from the distal tip of the device.The broken portion was not received.The four (4) distal sharp edges show wear and small nicks over the full length.On the proximal end an area of flattening was observed consistent with light impact.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.Based on the date of manufactured (28.Aug.2006) the drawings 14mm cannulated awl and awe tip (component), reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed as recommended.No definitive root cause was able to be determined as circumstances surrounding the event and over the devices roughly 10+ year lifespan are unknown.The returned part was determined to be suitable for the intended use when employed 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: 14.0MM CANNULATED AWL
• Common Device Name: AWL
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6193328
• Report Number: 3003875359-2016-10655
• Device Sequence Number: 13465888
• Product Code: HWJ
• UDI-Device Identifier: 10886982067142
• UDI-Public: (01)10886982067142(10)1544254
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2016

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: 03.010.041
• Device Lot Number: 1544254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1