MAUDE Adverse Event Report: SYNTHES HAGENDORF 2.8MM THREADED DRILL GUIDE

Catalog Number	323.027
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Reporter phone number and address is not provided for reporting.A device history record (dhr) review was performed for part # 323.027, lot # 9131731: manufacturing location: (b)(4), manufacturing date: 12.Sep.2014: 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
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the devices were used in the open reduction internal fixation (orif) surgery to the fibula on (b)(6) 2017.It was found that the drill guides in question could not be locked to the plate.So, the surgeon drilled the bone manually.No delay in surgery or adverse consequence to the patient was reported.Procedure was completed successfully.Concomitant device reported: plate (part # unknown, lot # unknown, quantity 1).This report is for one (1) 2.8mm threaded drill guide.This is report 2 of 4 for complaint (b)(6).
Additional Manufacturer Narrative
Returned devices were forwarded to the manufacture site for investigation.1x article 323.027 lot 9825162 / lcp drill sleeve.3x article 323.027 lot 9131731 / lcp drill sleeve.As received condition of device: the article is in a used condition.On the conical thread a slight traces of use present.Conclusion: during manufacturing investigation, all relevant and significant characteristics were checked and all results are within the specification.Especially the conical thread, which could not get locked into the implant plate, was reported on this complaint.The conical lcp 2.0 threads of the drill sleeves 323.034 were checked by functional gage.The values for the thread zero point for the lcp thread 3.5 are within specification of 0 ±0.15mm.Same values are on the inspection sheet where a 100% inspection of the lcp thread 3.5 at production is required in accordance to the test results, the conical thread of the lcp drill sleeve 3.5, 323.027 will fit into the implant plate holes.No production failure was found during investigation.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.Dhr-review: 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.No production failure was found during investigation.Root cause of complained issue not found.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: 2.8MM THREADED DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6858759
• Report Number: 3003875359-2017-10449
• Device Sequence Number: 16320217
• Product Code: FZX
• UDI-Device Identifier: 07611819245907
• UDI-Public: (01)07611819245907(10)9131731
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

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: 323.027
• Device Lot Number: 9131731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 10/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1