MAUDE Adverse Event Report: SYNTHES GMBH 1.1MM DRILL BIT/STRYKER J-LTCH WITH 8MM STOP/44.5MM; DRILL, BONE, POWERED

Catalog Number 317.180

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

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

Additional narrative: additional device product codes: hbe, erl.Initial reporter is a j&j sales representative.The subject 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 depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022 during a forehead lift surgery, to insert a screw a surgeon drilled with a drill bit ø 1.5 mm drill with stop, length 44.5 / 8 mm, 2-flute, for j-latch coupling with a diameter of 1.5 mm, and while doing so the end of the drill bit broke and remained inside the patient's skull.The surgeon then replaced the drill bit and performed another drilling nearby.The screw was inserted into the additional hole and the procedure was completed without any intervention and surgical delay.The procedure was successfully completed.This report is for one (1) 1.1mm drill bit/stryker j-ltch with 8mm stop/44.5mm.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: h3, h4, h6: part 317.180, lot f-26786: manufacturing site: selzach.Release to warehouse date: february 02, 2019.Supplier:(b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that the drill bit was broken.The broken fragment was not returned.Embedded device condition cannot be confirmed since x-ray evidence was not provided.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.The current and manufactured drawings were reviewed; no design issues or discrepancies were identified.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 device 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.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/STRYKER J-LTCH WITH 8MM STOP/44.5MM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13524334
• MDR Text Key: 286954840
• Report Number: 8030965-2022-00869
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 07611819020559
• UDI-Public: (01)07611819020559
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317.180
• Device Lot Number: F-26786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2019
• 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
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Sex: Female