MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLOTTED MALLET; HAMMER, SURGICAL

Model Number PDL102

Device Problems Break (1069); Component Missing (2306); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is synthes employee.The device has been 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 Description

It was reported on (b)(6) 2019, the repair technician found that the slotted mallet polyethylene cap was broken and parts missing.There is still adhesive found on the part.This was discovered by the service and repair department.There is no patient involvement.This report is for one (1) slotted mallet.This is report 1 of 1 for complaint (b)(4).

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.H3, h4, h6: part pdl102, lot t124455: manufacturing site: tuttlingen.Release to warehouse date: november 06, 2015.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.H3, h6: a service and repair evaluation was completed: the customer reported the slotted mallet polyethylene cap was broken and parts were missing.The repair technician reported the polyethylene cap is broken, part is missing, and there is glue residue on the part.Unauthorized repair is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.H3, h6: a product investigation was completed: the slotted mallet was received.The device was assembled, but the head was loose.The assembly would jingle and move slightly when held by the handle and waved.The weld between the head and shaft was found partially cracked.On the full metal half of the head, there were many small dents and scratches.On the other half of the head, the polyethylene mallet impact surface subcomponent was missing.The metal portion of that half was coated in a yellow film that covers the recess and wraps onto the sides of the mallet.When the yellow film was peeled back, the material underneath in the recess was found to be the polyethylene remains of the missing mallet impact surface.At the slot of the mallet, there were a number of scratches.No other issues could be identified with the returned portions of the device.The relevant drawings were reviewed.The complaint was confirmed for the slotted mallet.The mallet impact surface subcomponent had broken off, and only the stem portion of the subcomponent remained in the head of the slotted mallet.The rest of the subcomponent was not received.The head of the device was found to covered in scratches and dents, and where the mallet impact surface was missing was instead a yellow film coating that covered and wrapped around the recess where the fragment of the mallet impact surface remained.The service & repair evaluation confirmed that the yellow substance was residual adhesive.The mallet was found to have a loose assembly due to a crack in the weld between the head and shaft.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.No definitive root cause could 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: SLOTTED MALLET
• Type of Device: HAMMER, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8813831
• MDR Text Key: 151858709
• Report Number: 2939274-2019-59311
• Device Sequence Number: 1
• Product Code: FZY
• UDI-Device Identifier: 10705034700205
• UDI-Public: (01)10705034700205
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PDL102
• Device Catalogue Number: PDL102
• Device Lot Number: T124455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1