MAUDE Adverse Event Report: SYNTHES GMBH 1.1MM DRILL BIT/MINI QC/55MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number 310.110

Device Problems Break (1069); Entrapment of Device (1212); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

Additional product code: gff, gfa, hwe.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2021, the patient underwent the open reduction internal fixation surgery for right lesser toe fracture with the drill bit in question.During the surgery, it was found that the drill bit was deformed and rotated eccentrically.The surgeon used it since it was the only drill bit, and after the drill bit passing through a drill sleeve.Surgeon tried to straighten the bend in the drill bit by moving the drill bit with power tools back and forth in the sleeve several times.This action seemed to correct the bending of the drill bit a little, and the surgeon used it in the body.Drilling was performed without any issues.Later, after removing the drill bit from the patient's body, a nurse checked the drill bit and found that the tip of the drill bit was broken and remained in the body.The surgeon removed the remaining drill bit from the patient's body.Procedure was completed successfully without any surgical delay.This report is for (1) 1.1mm drill bit/mini qc/55mm.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: visual analysis of the returned sample revealed that drill bit ø1.1 l60/35 2flute the drill bit was broken, and broken piece was returned, and the shaft of the drill bit is bent, and no other issues were identified however the embedded condition cannot be confirmed since no x rays were provided.The dimensional inspection was performed for drill bit ø1.1 l60/35 2flute and it is within the specification limit.The observed condition drill bit ø1.1 l60/35 2flute in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 broken condition of the drill bit ø1.1 l60/35 2flute.While no definitive root cause could be determined, it is probable that the drill bit ø1.1 l60/35 2flute was broken due to the unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot : part: 310.110.Lot: f-28593.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: 21 october 2019.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were 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.

• Brand Name: 1.1MM DRILL BIT/MINI QC/55MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12380143
• MDR Text Key: 268721753
• Report Number: 8030965-2021-07320
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819018501
• UDI-Public: (01)07611819018501
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 310.110
• Device Lot Number: F-28593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/10/2021
• Supplement Dates FDA Received: 10/07/2021
• Patient Sequence Number: 1