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
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 unknown date, during field inspection at the sterile processing department (spd), it was noticed that the end of yellow long scalpel handle holder was broken off.The broken off piece was not found in the set.There was no patient involvement.This report is for one (1) long scalpel handle.This is report 1 of 1 for complaint (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, h6: device history lot part number: 03.010.491, synthes lot number: h253194, supplier lot number: n/a, release to warehouse date: 07-apr-2017, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Device history batch null, device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.
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, h6: product investigation was completed.Visual inspection of the returned device confirmed the condition of device breakage, which agrees with the reported complaint condition.A portion of the distal tip has broken off at the radius transition and was not returned.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.A definitive assignable root cause for the device breaking could not be determined based on the provided information.The most likely cause is excessive lever force.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 8374799
• Report Number: 2939274-2019-56701
• Device Sequence Number: 1620379
• Product Code: GDZ
• UDI-Device Identifier: 10886982069085
• UDI-Public: (01)10886982069085
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2019

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: H253194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 02/02/2019
• Supplement Date Received by Manufacturer: 03/11/2019; 03/28/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/26/2019; 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1