MAUDE Adverse Event Report: SYNTHES GMBH 1.8MM DRILL BIT/QC/100MM; DRILL, BONE, POWERED

Model Number 310.510

Device Problem Break (1069)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part # 310.510, synthes lot # u256097, supplier lot # u256097, release to warehouse date: january 31, 2017, supplier: (b)(4), no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the 1.8mm drill bit/qc/100mm (part #: 310.510, lot #: u256097) was received at us customer quality (cq).Upon visual inspection, the tip of the drill bit was broken off device failure/defect identified? yes.Dimensional inspection: specified dimensions: shaft od.Measured dimensions: shaft od = conforming.Device used ¿ hand micrometer.Document/specification review: current and manufacture revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the tip of the drill bit was broken off.Although no definitive root cause could be determined based on the provided information, it is likely that the device experienced excessive forces.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 the 1.8mm drill bit was bent and 2.0mm drill bit was dull.This report is for one (1) 1.8mm drill bit/qc/100mm.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 1.8MM DRILL BIT/QC/100MM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12812688
• MDR Text Key: 282357677
• Report Number: 8030965-2021-09505
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587035154
• UDI-Public: (01)10887587035154
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310.510
• Device Catalogue Number: 310.510
• Device Lot Number: U256097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• 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
• Patient Age: 52 YR