MAUDE Adverse Event Report: SYNTHES HAGENDORF 2.0MM ANGLED AWL; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Catalog Number	03.617.993
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	01/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Reported concomitant devices: zero-p va spacer with interbody plate (part: 04.647.129s lot: 9370106, quantity: 1).(b)(6).Device history records review was conducted.Part: 03.617.993 lot: 3478262.Manufacturing location: (b)(4).Manufacturing date: 07.July 2010.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.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 after placement of zero-profile variable angle (zero-p va) spacer with interbody plate the first screw hole was prepared with the angled awl during surgery on (b)(6) 2017.When turning out with slight rotation, possibly light lever, the tip of the awl broke off and has been left in the vertebral body.No removal surgery planned yet.Therefore, the zero-p va could only be fixed with one screw.There was no prolongation of surgery.Complaint involves 1 part.Reported concomitant devices: zero-p va spacer with interbody plate (part: 04.647.129s, lot: 9370106, quantity: 1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional 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
A product development investigation was performed for the subject device (2.0mm angled awl, part number 03.617.993, lot number 3478262).The subject device was returned with the complaint condition stating the tip (14mm) of the awl is broken off.We are not able to determine the exact cause of this occurrence.We can only assume that a mechanical overload, created by an exceptional hard bone, angle failure during use or the three-edged wedge blades are blunt caused the breakage of the tip.The review of the manufacturing documents revealed that the present instrument was manufactured in july 2010, also the hardness of the broken awl tip and the diameter are within the documented specification.No manufacturing related issues were found.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.No product fault could be detected.Complaint is disposed as confirmed due to evidence that part is broken, but it's considered not valid for manufacturing standpoint because there is no evidence of issues manufacturing related.Unfortunately, we are not able to determine the exact reason for this occurrence, but we reasonably conclude that the breakage was caused by mechanical overloading during use.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: 2.0MM ANGLED AWL
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6309625
• Report Number: 3003875359-2017-10055
• Device Sequence Number: 1252011
• Product Code: KWQ
• UDI-Device Identifier: 10705034717401
• UDI-Public: (01)10705034717401(10)3478262
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2017

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: 03.617.993
• Device Lot Number: 3478262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 03/03/2017; 03/22/2017
• 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: 60 YR