MAUDE Adverse Event Report: SYNTHES GMBH 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM; BIT, DRILL

Model Number	03.130.200
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, the surgeon was fixing a broken finger and the drill bit broke, and a portion was left in the patient.The patient had super hard bone.The piece was not removed and the surgery was completed successfully.This report involves one 1.1mm drill bit/k-wire attachment for threaded hole/70mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
(b)(4).The endoscope was received by pentax medical for evaluation on 01-dec-2022.The endoscope was inspected by pentax medical service under work order (b)(4) and the technician was unable to duplicate the user complaint and documented the following inspection findings: customer complaint findings: customer complaint not duplicate, scope leak test function: dry leak test pass, scope leak test function: wet leak test pass, scope electrical test function: dst electrical safety test pass, scope electrical test function, scope electrical test function: resistance electrical test pass, r/l lock knob.The investigation is inprocess.If additional information becomes available, a supplemental report will be filed with the new information.
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, h4, h6: part 03.130.200, lot f-34059: release to warehouse date: december 09, 2021.Manufacturing site: werk selzach.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: a photo investigation was completed: visual analysis of the photo revealed that the drill bit had no signs of issue.The complaint condition of breakage cannot be confirmed since the device is not clearly shown in the picture and embedding of the fragment is not confirmed as x-ray evidence was not provided.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15945527
• Report Number: 8030965-2022-10839
• Device Sequence Number: 6442804
• Product Code: HTW
• UDI-Device Identifier: 10886982075314
• UDI-Public: 10886982075314
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Model Number: 03.130.200
• Device Catalogue Number: 03.130.200
• Device Lot Number: F-34059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown