MAUDE Adverse Event Report: SYNTHES GMBH 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE; NAIL, FIXATION, BONE

Catalog Number	03.010.438S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, the pin had fallen out of the tna driving cap.During the procedure, a tna nail was inserted, but then removed to dial in the reduction.When the nail was extracted, it was noticed that the poly inserted distally had moved outside of the nail, the surgical tech was not able to put back into the nail, and a new nail was selected.This nail was also extracted for repositioning and the sleeve had moved as well, but surgeon decided to move forward and drill through the poly insert.Additionally, the surgeon was having issues inserting the nail through the suprapatellar protection sleeve, so it was removed and the nail was inserted without the sleeve.During the surgery, the surgeon used a drill bit in a ¿blocking¿ fashion to redirect the nail, but the drill bit was unable to remain stable because of the comminution.Then a blocking screw was used.The surgery was successfully completed with no surgical delay.There was no adverse patient impact.No further information is available.This report is for a 14.5mm outer protection sleeve for suprapatellar ¿ sterile.This is report 3 of 4 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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is 31-july-2023.H3, h6: 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.
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.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 history lot manufacturing location: supplier ¿ (b)(4) / inspected, packaged and released by: monument.Release to warehouse date: 05-may-2023.Expiration date: 31-mar-2025.Part number: 03.010.438s, 14.5mm outer protection sleeve for suprapatellar - sterile.Lot number: 4689p61 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Certificate of analysis supplied by (b)(4) dated 06-apr-2023 was reviewed and determined to be conforming.Inspection certificate met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.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: 14.5MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17548588
• Report Number: 8030965-2023-10299
• Device Sequence Number: 6967025
• Product Code: JDS
• UDI-Device Identifier: 10886982068798
• UDI-Public: (01)10886982068798
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 03/31/2025
• Device Catalogue Number: 03.010.438S
• Device Lot Number: 4689P61
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.2 3-FLTD DRILL BIT QC/NEEDLE PT/145; DRIVING CAP; TIBIAL NAIL-ADVANCED / 12 345 / STERILE; TIBIAL NAIL-ADVANCED / 12 345 / STERILE; UNK - SCREWS: TRAUMA
• Patient Age: 44 YR
• Patient Sex: Male