MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM; BIT,DRILL

Model Number 03.010.078

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.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 Description

It was reported that on an unknown date, the reporter found six (6) damaged items in sterile processing department (spd).There was no patient involvement.This complaint involves six (6) devices.This report is for (1) 4.5mm/6.5mm stepped drill bit large qc/485mm.This is report 1 of 1 for (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.H3, h6: a product investigation was conducted.Visual inspection: the 4.5mm/6.5mm stepped drill bit large qc/485mm (p/n 03.010.078; s/n pe03364) was received at customer quality, and upon visual inspection, it was observed that a portion of the distal tip of the drill bit was broken off.Dimensional inspection: the major diameter of the drill bit was measured per relevant drawing.The measuring result does show conformity.Document/ specification review: the relevant drawing(s) was reviewed: a review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformances were identified.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.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 because 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.H3, h4, h6: a device history record (dhr) review was conducted: part number:03.010.078, synthes lot number: pe03364, supplier lot number: n/a, release to warehouse date: 27feb2018, expiration date: n/a.Supplier: (b)(4).Nr was generated during production for 145 parts outside of parameters.Since the supplier's process for these parameters had been validated to ensure curing of the epoxy ink all parts were accepted.This non-conformance is not relevant to the complaint condition since it is not related to damaged items.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.G4: the incorrect g4 date was inadvertently utilized in initial medwatch.The correct date is june 30, 2020.  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

During manufacturer's preliminary investigation of the returned devices on june 30, 2020 it was identified that a portion of the distal tip of the drill bit was broken off.This is report 4 of 4 for (b)(4).

• Brand Name: 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM
• Type of Device: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10245510
• MDR Text Key: 197984858
• Report Number: 2939274-2020-03155
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982067487
• UDI-Public: (01)10886982067487
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 03.010.078
• Device Catalogue Number: 03.010.078
• Device Lot Number: PE03364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 14MM CANNULATED DRILL BIT FLEXIBLE; DRIVING CAP/THREADED; HYBRID INSERTION HANDLE; 14MM CANNULATED DRILL BIT FLEXIBLE; DRIVING CAP/THREADED; HYBRID INSERTION HANDLE