MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER; DRIVER, WIRE, AND BONE DRILL, MANUAL

Catalog Number 03.505.041

Device Problem Failure to Cut (2587)

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

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, during a ssro procedure for jaw deformity of the mandible, the surgeon attempted to perforate the mandible using the drill bit but it was not sharp enough to drill.Another drill bit was used to complete the procedure.The surgeon then attempted to insert a screw into the perforated hole, but the screwdriver would not hold the screw.The surgery was completed successfully with no surgical delay.No further information is available.This report is for one (1) 1.5mm dia drill bit w/6mm stop 13mm length f/90° screwdriver this is report 1 of 2 for (b)(4).

Manufacturer Narrative

Initial reporter is synthes employee without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: 1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER
• Type of Device: DRIVER, WIRE, AND BONE DRILL, MANUAL
• 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: 13689221
• MDR Text Key: 287273351
• Report Number: 8030965-2022-01417
• Device Sequence Number: 1
• Product Code: DZJ
• UDI-Device Identifier: 07611819187597
• UDI-Public: (01)07611819187597
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082649
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.505.041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SCRDRIVER SHAFT MATMIDF SELF-HOLD; SCRDRIVER SHAFT MATMIDF SELF-HOLD; UNK - PLATES: MATRIXMIDFACE; UNK - SCREWS: MATRIXMIDFACE