MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE; NAIL, FIXATION, BONE

Model Number	03.010.437S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that on (b)(6) 2021, patient underwent a surgical procedure for unknown reason.While completing tibial nail, the surgeon was removing the suprapatellar sleeve from the knee.It was noticed that a small piece was missing from the sleeve; it is unknown where the piece ended up.The surgery was successfully completed.There was no surgical delay reported.Fragments were generated.There was no patient consequence.This report is for a suprapatellar 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.H3, h4, h6: manufacturing location: supplier ¿ (b)(4), packaged and released by: monument, release to warehouse date: 28-jun-2021, expiration date: 31-may-2023, part number: 03.010.437s, 12.0mm outer protection sleeve for suprapatellar - sterile, lot number: 87p6321 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Certificate of analysis was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 20131 supplied by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12413837
• Report Number: 2939274-2021-05124
• Device Sequence Number: 4377927
• Product Code: JDS
• UDI-Device Identifier: 10886982068781
• UDI-Public: (01)10886982068781
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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 Expiration Date: 05/31/2023
• Device Model Number: 03.010.437S
• Device Catalogue Number: 03.010.437S
• Device Lot Number: 87P6321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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 - NAILS: TIBIAL; UNK - NAILS: TIBIAL
• Patient Age: 38 YR
• Patient Weight: 64