MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.25MM/1.6MM PROTECTION SLEEVE; BONE PLATE

Model Number	395.902
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.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 or Problem Description
It was reported that on (b)(6) 2019, during evaluation the loaner department found the protection sleeve was broken.There was no patient involvement.This complaint involved one (1) device.This is 1 of 1 for report (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.Part: 395.902.Lot: 8888536.Manufacturing site: bettlach.Release to warehouse date: 04.April 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the 1.25mm/1.6mm protection sleeve (part # 395.902 / lot # 8888536) was received at us cq.The diameter 1.25mm drill guide of the device has broke off the main body.The hard-solder that joined the sleeve to the body failed.The received condition was consistent with the complaint condition thus the compliant was confirmed.Device failure/defect identified? yes; drill guide was broken off the body.Hard-solder failed.Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage conclusion: the overall complaint was confirmed for the received 1.25mm/1.6mm protection sleeve (part # 395.902 / lot # 8888536) as the 1.25mm drill guide broke off the body.The hard-solder that joined the sleeve to the body failed.Although no definitive root-cause can be determined, it is possible the device experienced unintended forces leading to the device breakage.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: 1.25MM/1.6MM PROTECTION SLEEVE
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9268190
• Report Number: 2939274-2019-61899
• Device Sequence Number: 2244297
• Product Code: JEY
• UDI-Device Identifier: 10886982200884
• UDI-Public: (01)10886982200884
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K971987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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
• Operator of Device: Health Professional
• Device Model Number: 395.902
• Device Catalogue Number: 395902
• Device Lot Number: 8888536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/06/2019
• Patient Sequence Number: 1