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

Model Number	03.010.491
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.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 (b)(6) 2021, two (2) star/hex drive screwdriver, one (1) driving cap/threaded, one (1) long scalpel handle, one (1) cannulated hexagonal screwdriver, and one (1) hexagonal screwdriver were damaged products.It is unknown if there were patient and procedure involvement.There is no further information available.This report is for one (1) long scalpel handle.This is report 4 of 6 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6- the complaint can be confirmed since the device received with the broken scalpel tip, which could have also contributed to the device interaction problem.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 lot = > part #: 03.010.491.Synthes lot #: 9854574.Supplier lot #: 9854574.Release to warehouse date: 19 nov 2015.Supplier: (b)(4).No ncr's generated during production.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.

• 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: 12204049
• Report Number: 2939274-2021-04184
• Device Sequence Number: 4371239
• Product Code: GDZ
• UDI-Device Identifier: 10886982069085
• UDI-Public: 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: 03.010.491
• Device Catalogue Number: 03.010.491
• Device Lot Number: 9854574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1