MAUDE Adverse Event Report: SYNTHES GMBH 2.5MM CALIBRATED DRILL BIT QC 250MM/95MM; BIT, DRILL

Catalog Number	03.113.023
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthese reports an event in colombia as follows: it was reported that the device was received as a blind unit from colombia on (b)(6) 2022.There was no allegation reported against the device.Upon product return and investigation on (b)(6) 2023, it was found that the item was broken from the distal tip.No further information is available.This report involves one 2.5mm calibrated drill bit qc 250mm/95mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthos is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a j&j employee.Part:03.113.023 lot:l203045 manufacturing site: werk bettlach supplier: na release to warehouse date:(b)(6) 2016 expiration date: na a manufacturing record evaluation was performed for the finished article lot and no non-conformance's were identified.The product was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the drill bit ø2.5 w/stop caliber l250/225 f/ was broken from the distal tip, fragment was not returned for evaluation.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Additionally, the stop ring was missing from the device.A dimensional inspection for the drill bit ø2.5 w/stop caliber l250/225 f/ was unable to be performed due to post manufacturing damage.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the drill bit ø2.5 w/stop caliber l250/225 f/.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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 CALIBRATED DRILL BIT QC 250MM/95MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16708713
• Report Number: 8030965-2023-04372
• Device Sequence Number: 6080381
• Product Code: HTW
• UDI-Device Identifier: 07611819351813
• UDI-Public: (01)07611819351813
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.113.023
• Device Lot Number: L203045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown