MAUDE Adverse Event Report: SYNTHES GMBH LONG SCALPEL HANDLE; HANDLE, SCALPEL

Model Number	03.010.491
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary : the following device was received as blind unit for the following products: 03.043.029; 2023519, 319.006; h521672, 319.006; a4gj568, 03.010.523; 9570803, 03.010.523; l759640, 03.010.523; 31p5810, 03.010.523; 9850771, 03.010.491; h884724, 03.037.017; 9764853, 393.10; unk, 03.033.001; l750728, 03.118.111; t981020.Tracking number: (b)(4).No additional information is known.However, it couldn¿t be associated with a complaint or any other existing record.This complaint involves six (6) devices.The subject device has been received at depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that long scalpel handle was broken from the tip.The broken fragment was not returned for examination.No other issues were found.A dimensional inspection for the long scalpel handle was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the long scalpel handle would contribute to the complained device issue.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 drawing/specifications reviewed the following source controlled drawings reflecting the current and manufactured revisions were reviewed: dimensional inspection: n/a.Device history lot.Part #: 03.010.491, synthes lot #:h884724, supplier lot #:h884724, release to warehouse date: 15 apr 2020, suppliers: (b)(4).No ncr's generated during production.Device history batch null, device history review 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.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 or Problem Description
The following device was received as blind unit for the following products: it was reported that the visual analysis of the returned sample revealed that visual analysis of the returned sample revealed that long scalpel handle was broken from the tip.The broken fragment was not returned for examination.No other issues were found.No additional information is known.However, it couldn¿t be associated with a complaint or any other existing record.This complaint involves six (6) devices.This report is for one (1) long scalpel handle.This is report 3 of 6 for complaint (b)(4).

• Brand Name: LONG SCALPEL HANDLE
• Common Device Name: HANDLE, SCALPEL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16482392
• Report Number: 8030965-2023-02647
• Device Sequence Number: 7578996
• Product Code: GDZ
• UDI-Device Identifier: 10886982069085
• UDI-Public: (01)10886982069085
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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 Model Number: 03.010.491
• Device Catalogue Number: 03.010.491
• Device Lot Number: H884724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AIM-ARM RADIOLUC; BLADE/SCREW GUIDE SLEEVE; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DRIVING CAP/THREADED; DRIVING CAP/THREADED; DRIVING CAP/THREADED; DRIVING CAP/THREADED; RADIOLUCENT INSERTION HANDLE FRN; SILICONE HNDL/QC ROTATING CAP; UNIVERSAL CHUCK WITH T-HANDLE
• Patient Sex: Unknown