MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8.0MM DRILL BIT FOR DHS/DCS TRIPLE REAMER; BIT, DRILL

Catalog Number 338.100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: synthes sales consultant.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the drill bit in the dynamic hip screw (dhs) set was dull during hip surgery.While using the drill bit, the bone can be burned causing bone necrosis and not having the best patient outcome.When the event occurred, they continued the case but set the instrument aside until replacement was issued.There was no surgical delay reported.The procedure was successfully completed.There was no patient consequence.This complaint involves one (1) device.This report is 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, h4, h6: a review of the device history record device history lot part: 338.100, lot: 1941865, manufacturing site: hägendorf, release to warehouse date: 28.October 2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary background: it was reported that on (b)(6) 2019, the drill bit in the dynamic hip screw (dhs) set was dull during hip surgery.While using the drill bit, the bone can be burned causing bone necrosis and not having the best patient outcome.When the event occurred, they continued the case but set the instrument aside until replacement was issued.There was no surgical delay reported.The procedure was successfully completed.There was no patient consequence.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the drill bit ø8 l245 f/dhs/dcs-syst (p/n 338.100 lot 1941865) was received showing a blunted drill tip.The drill tip was observed to be dull from consistent use and device wear over the part¿s lifetime (10+ years).No other issues were identified with the returned components of the device.Conclusion: after a visual inspection it is determined that the reusable instrument is worn from repeated use and servicing (10+ years); therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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: 8.0MM DRILL BIT FOR DHS/DCS TRIPLE REAMER
• 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: 8719983
• MDR Text Key: 148750931
• Report Number: 2939274-2019-58802
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819021983
• UDI-Public: (01)07611819021983
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 338.100
• Device Lot Number: 1941865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Manufacturer Received: 05/24/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 07/30/2019
• Patient Sequence Number: 1