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 Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes reports an event in canada as follows: it was reported that the aiming guide was bent and unable to pass the drill bit due to a curve in the guide tube.There was no patient consequence.Concomitant device reported: unknown drill bit (part # unknown, lot # unknown, quantity unknown).This report is for 1 2.4mm/1.8mm double drill sleeve.This is report 1 of 1 for (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.Investigation summary: visual inspection: the 2.4mm/1.8mm double drill sleeve (p/n: 312.18, lot #: 3089091) was returned and received at us cq.Upon visual inspection, the 1.8 mm drill guide was observed to be bent and deformed.No other issues were observed with the returned device.Dimensional inspection: the inner diameter of the 2.40 mm drill guide was measured to be within the specification.The complaint relevant dimensions of the 1.8 mm drill guide cannot be checked for dimensional accuracy, because of the damage.Document/specification review : based on the date of manufacture, the current and manufactured revision of drawings were reviewed : 1.8 mm/2.4 mm double drill guide: 2.4mm drill guide: complaint confirmed? yes, the device received was bent and deformed.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the 2.4mm/1.8mm double drill sleeve (p/n: 312.18, lot #: 3089091).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 history lot: part: 312.180.Lot: 3089091.Manufacturing site: hägendorf.Release to warehouse date: feb 12, 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 2.4MM/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: 10862251
• Report Number: 2939274-2020-05212
• Device Sequence Number: 19483444
• Product Code: FZX
• UDI-Device Identifier: 10887587036540
• UDI-Public: (01)10887587036540
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2020

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: 3089091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: TRAUMA; UNK - DRILL BITS: TRAUMA