MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE

Catalog Number	323.061
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Supplier lot number reported as 1402524.A review of the device history records has been requested.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 or Problem Description
It was reported that on (b)(6) 2018, during an open reduction and internal fixation (orif) clavicle procedure, the unknown drill was lodged in the threaded drill guide with depth gauge and was unable to be used.The surgeon removed the unknown drill from the drill guide by pulling and using a twisting motion.An indention was found on the inner part of the drill guide and was believed that indention was the cause of the incident.There was no surgical delay.The procedure was successfully completed.Patient status is unknown.Concomitant device reported: drill (part #232.Unknown, lot #unknown, quantity #1).This report is for one (1) 2.0mm threaded drill guide with depth gauge.This is report 1 of 1 for complaint (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.Investigation summary complaint description: it was reported that on an unknown date, during a clavicle case, the threaded drill guide with depth gauge was used and bent in a way to advanced the drill through the drill guide.It is unknown if there was surgical delay.Procedure and patient outcome is unknown.Visual inspection: the returned device was examined, and the distal threaded tip was found to be stripped.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed, however an analysis code of visual : stripped/worn/twisted/cross threaded better captures the observed failure.No further visual defects or deficiencies were noted.Conclusion: after a visual inspection per guidance provided in windchill, it is determined that the reusable instrument is worn from repeated use and servicing; 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 history records part: 323.061, lot: 1402524, manufacturing site: haegendorf, release to warehouse date: 12.Dec.2005.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Device history batch, device history review: review of the device history record showed that there were no issues during the manufacture of this product 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.
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.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: 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8127116
• Report Number: 2939274-2018-55232
• Device Sequence Number: 16577456
• Product Code: FZX
• UDI-Device Identifier: 10886982190741
• UDI-Public: (01)10886982190741
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2018

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 Catalogue Number: 323.061
• Device Lot Number: 1402524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 01/07/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/04/2019; 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR