MAUDE Adverse Event Report: SYNTHES GMBH LCP DRILL BIT Ø2.8 W/STOP L165 2FLUTE; BIT, DRILL

Catalog Number 310.284

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/29/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: reporter is a j&j employee.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.The device has been 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during surgery, the 2.8 drill bit (ref.310.284 ) broke while drilling the patient's bone, so part of it remains inside the bone, making its removal impossible.The other bit fragment is marked with red tape.This event did not delay surgery, nor did it generate any type of inconvenience or intra-surgical complication.This report is for one (1) lcp drill bit ø2.8 w/stop l165 2flute.This is report 1 of 1 for complaint (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a3, b2 h3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the distal shaft tip of lcp drill bit ø2.8 w/stop l165 2flute has broken.The broken fragments was not returned.No other problem was reported.The embedded device condition its cannot be confirmed due to lack evidence.A dimensional inspection for the lcp drill bit ø2.8 w/stop l165 2flute was unable to be performed due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the lcp drill bit ø2.8 w/stop l165 2flute would contribute to the complained device issue.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.H3, h4, h6: a device history record (dhr) review was conducted: part # 310.284 lot # 402p497 manufacturing site: jabil bettlach release to warehouse date: 28.October.2021 a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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.B1, b3.

• Brand Name: LCP DRILL BIT Ø2.8 W/STOP L165 2FLUTE
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14679661
• MDR Text Key: 294780606
• Report Number: 8030965-2022-03939
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819245891
• UDI-Public: (01)07611819245891
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.284
• Device Lot Number: 402P497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male