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 Break (1069)

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

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the device was not returned.A photo-investigation was performed on the images dhr could not be completed because the lot number was not known.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.The complaint condition is being confirmed during photo/video 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: lot unknown.Device history batch: null.Device history review: a dhr could not be completed because the lot number was not known.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, during an unknown procedure, the drill bit broke.No patient consequence was reported.This report is for one (1) 2.5mm drill bit/qc/gold/110mm this is report 1 of 1 for (b)(4).

• 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
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11761918
• MDR Text Key: 249052519
• Report Number: 8030965-2021-03498
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 07611819018631
• UDI-Public: (01)07611819018631
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1