MAUDE Adverse Event Report: SYNTHES HAGENDORF 14.0MM CANNULATED AWL

Catalog Number 03.010.041

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 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).

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
• Type of Device: AWL
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6193328
• MDR Text Key: 62969117
• Report Number: 3003875359-2016-10655
• Device Sequence Number: 1
• Product Code: HWJ
• UDI-Device Identifier: 10886982067142
• UDI-Public: (01)10886982067142(10)1544254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1