MAUDE Adverse Event Report: SYNTHES GMBH UNK - DRILL BITS: TRAUMA; BIT, DRILL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown drill bit/ unknown lot.Potential part numbers reported as 03.133.100, 03.133.101, 03.133.102, 03.133.103, 03.133.104, 03.133.105, 03.133.106, 03.133.107, 03.133.108, 03.133.109, 03.133.110.Exact part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that during an osteosynthesis of the clavicle with a locking compression (lcp) plate, the drill bit shot through while drilling the second cortex.As a consequence, one of the main blood structures got damaged.The bleeding resulted in a cpr per-operative.The blood vessel got ligatured.The collateral blood vessels will take over the circulation.There was surgical delay of over sixty (60) minutes due to the reported event.In 4 weeks, the surgeon has a follow-up appointment with the patient.No further information provided.Concomitant device reported: unknown lcp clavicle plate (part # unknown, lot # unknown, quantity unknown).This report is for one (1) unknown 3.2mm drill bit.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.H10 additional narrative: h3, h4, h6: 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: UNK - DRILL BITS: TRAUMA
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10929706
• MDR Text Key: 219138932
• Report Number: 8030965-2020-09303
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2020
• Patient Sequence Number: 1
• Treatment: UNK - PLATES; UNK - PLATES
• Patient Outcome(s): Required Intervention