MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.1MM DRILL BIT/STRYKER J-LTCH WITH 8MM STOP/44.5MM; DRILL, BONE, POWERED

Model Number 317.18

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: erl and hbe.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

It was reported that on (b)(6) 2021, during a hand surgery procedure, the drill bits from 1.5mm craniofacial module (cmf) 1.1x8mm and 1.1x12mm broke during a digit and metacarpal orif.There was no surgical delay.It was unknown if the procedure was completed.The fragments of the broken devices were generated.Patient outcome is unknown.This report involves one (1) 1.1mm drill bit/stryker j-ltch with 8mm stop/44.5mm.This is report 1 of 2 for (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: d10 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): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12447499
• MDR Text Key: 270574730
• Report Number: 2939274-2021-05255
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587038353
• UDI-Public: (01)10887587038353
• Combination Product (y/n): N
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 317.18
• Device Catalogue Number: 317.18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1.1 DB/STRYKER J-LTCH 12 STOP/44.5; 1.1 DB/STRYKER J-LTCH 12 STOP/44.5; UNK - SCREWDRIVERS: CMF; UNK - SCREWDRIVERS: CMF; 1.1 DB/STRYKER J-LTCH 12 STOP/44.5; UNK - SCREWDRIVERS: CMF
• Patient Outcome(s): Required Intervention