MAUDE Adverse Event Report: SYNTHES GMBH 2.5MM DRILL BIT/QC/GOLD/110MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number 310.250

Device Problem Failure to Cut (2587)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: gfa; gff; hwe.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 during a procedure on (b)(6) 2021, it was noticed that the 2.5mm drill bit is blunt and screwdriver shaft 4.5 / 5 t25 stardrive is difficult to adapt with the torque limiter and with the handpiece.Also one pin of 1.25 is bent and another pin of 1.25 is split with other part remained inside the patient.No further information provided.This report is for one (1) 2.5mm drill bit/qc/gold/110mm.This is report 1 of 4 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.Photo investigation: the device was not returned.A photo-investigation was performed on all the images/attachments.The drill bit with product code: 310.250 / lot: 5l22644 cannot be confirmed based on the images provided.Also, the complaint condition cannot be confirmed based on the provided images.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition cannot be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot part: 310.250, lot: 5l22644, manufacturing site: bettlach, release to warehouse date: 26 july 2019.A manufacturing record evaluation was performed for the finished device lot number, 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: 2.5MM DRILL BIT/QC/GOLD/110MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11672553
• MDR Text Key: 245612345
• Report Number: 8030965-2021-02955
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819018631
• UDI-Public: (01)07611819018631
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.250
• Device Lot Number: 5L22644
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - EXTRACTION INSTRUMENTS; UNK - EXTRACTION INSTRUMENTS; UNK - POWERED DRIVERS/HANDPIECES; UNK - SCREWDRIVERS: SHAFTS; UNK - TORQUE DEVICES; UNK - EXTRACTION INSTRUMENTS; UNK - EXTRACTION INSTRUMENTS; UNK - POWERED DRIVERS/HANDPIECES; UNK - SCREWDRIVERS: SHAFTS; UNK - TORQUE DEVICES