MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.8MM THREADED DRILL GUIDE

Model Number	323.027
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported that during a procedure to treat an ankle fracture on (b)(6) 2019, the drill sleeve was broken, and the remaining part was stuck in an unknown plate, causing the plate to be obsolete.A new plate was used for the surgery.There was another device to complete the procedure.There were fragments generated from the broken device no medical intervention was needed.Procedure was successfully completed with a five (5) minute delay.Patient status is unknown.This report is for a 2.8 mm threaded drill guide.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part: 323.027; lot: 8683143; manufacturing site: hägendorf; release to warehouse date: december 04, 2013 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: visual inspection performed at customer quality (cq) identified the the distal thread of the sleeve has broken off and was not returned (piece is lodged into plate from the provided data).There is also deformation along the distal threads.No new issues were identified.A device failure was identified.Dimensional inspection: a dimensional inspection was not performed due to post manufacturing damage and the tapered nature of the distal threads.Document specification the following documents were reviewed as part of this investigation: --lcp drill sleeve 3.5 fir drill bits ø2.8 based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8722545
• Report Number: 8030965-2019-65549
• Device Sequence Number: 1729340
• Product Code: FZX
• UDI-Device Identifier: 10886982190581
• UDI-Public: (01)10886982190581
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2019

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 Model Number: 323.027
• Device Catalogue Number: 323.027
• Device Lot Number: 8683143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 05/25/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1