MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM/1.8MM DOUBLE DRILL SLEEVE; GUIDE

Model Number	312.18
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 on an unknown date that two (2) double drill sleeves were noticed bent/broken.It is unknown how the issue was discovered.These was found bent when checking the set and restocking them.It is unknown if there were patient and surgical involvement.This is report 2 of 2 of (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: device code.H3, h6: part: 312.180.Lot: 7951530.Manufacturing site: haegendorf.Release to warehouse date: 19.June 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the 2.4mm/1.8mm double drill sleeve (p/n: 312.18, lot number: 7951530) was received at us customer quality (cq).Upon visual inspection, the 1.8mm guide sleeve is deformed/bent and partially collapsed inwards.There was no evidence of breakage.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection could be performed due to post-manufacturing damage.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the 1.8mm guide sleeve is deformed and bent.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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.
Event or Problem Description
The issue was discovered during a routine equipment check after decontamination.There was no patient or surgical involvement.

• Brand Name: 2.4MM/1.8MM DOUBLE DRILL SLEEVE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9654994
• Report Number: 2939274-2020-00594
• Device Sequence Number: 2824334
• Product Code: FZX
• UDI-Device Identifier: 10887587036540
• UDI-Public: (01)10887587036540
• 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
• Report Date (Section B): 01/09/2020

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
• Operator of Device: Health Professional
• Device Model Number: 312.18
• Device Catalogue Number: 312.18
• Device Lot Number: 7951530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1