MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LONG SCALPEL HANDLE; HANDLE, SCALPEL

Model Number	03.010.491
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
It was reported that on an unknown date, a break on the tip of a long handle scalpel occurred during cleaning after use.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) long scalpel handle.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.H3, h4, h6 investigation summary.Visual inspection: the long scalpel handle (p/n: 03.010.491, lot number: 7927771) was received at us cq.Upon visual inspection, it was observed that the scalpel tip broke off of the complaint device.Additionally, scratches were observed on the scalpel tip around the breaking point.No damage or defect was noted to the remaining features or components of the returned device.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: scalpel tip width = 3.5 mm -0.01/- 0.03 mm.Measured dimensions: scalpel tip width (between weld and break) = 3.49 mm, conforming further dimensional inspection could not be performed due to device geometry.Document/specification review: the following document(s) were reviewed: scalpel assembly, scalpel tip, no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed as the scalpel tip broke off of the complaint device.Additionally, scratches were observed on the scalpel tip around the breaking point.No definitive root cause could be determined based on the provided information, although it is possible that unintended forces applied to the device could have contributed to the complaint condition.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 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 history: part #: 03.010.491, synthes lot number: 7927771, supplier lot number: 7927771, release to warehouse date: 17-jun-2015, supplier: avalign technologies - nemcomed.No ncrs were generated during production.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: LONG SCALPEL HANDLE
• Common Device Name: HANDLE, SCALPEL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10049357
• Report Number: 2939274-2020-02316
• Device Sequence Number: 19711424
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 7927771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1