MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM/6.5MM STEPPED DRILL BIT; 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.Investigation summary: investigation flow: damage.Visual inspection: the 4.5mm/6.5mm stepped drill bit large qc/485mm (p/n 03.010.078; s/n pe03364; quantity 2) were received at customer quality, and upon visual inspection, it was observed that a portion of the distal tip of the drill bits were broken off.Device failure/ defect identified? yes.Dimensional inspection: the major diameter of the drill bit got measured.Conclusion: the measuring result does show conformity.Document/ specification review: a review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformance's were identified.Complaint confirmed? yes.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.Device history lot: part number:03.010.078, synthes lot number: pe03364, supplier lot number: n/a, release to warehouse date: feb 27, 2018, expiration date: n/a, supplier: (b)(4).Nr-0080574 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.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.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.This is report 2 of 3 for (b)(4).

Event Description

Additional information: during manufacturer's investigation of the returned device it was observed that a portion of the distal tip of the drill bit was broken off.This device condition was reassessed and determined to be reportable on june 30, 2020.This is report 2 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5; d4 h11 corrected data: h6: corrected data: product investigation: visual inspection: the 4.5mm/6.5mm stepped drill bit large qc/485mm (p/n (b)(6) s/n (b)(6)) 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.G3 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: 4.5MM/6.5MM STEPPED DRILL BIT
• 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: 10247755
• MDR Text Key: 198296448
• Report Number: 2939274-2020-03158
• 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: 06/30/2020

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: 06/30/2020
• 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.