MAUDE Adverse Event Report: SYNTHES GMBH 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE; NAIL, FIXATION, BONE

Catalog Number	03.010.437S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.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), 2023, the 12.0mm suprapatellar outer protection sleeve disengaged from the handle at some point in the procedure.When the insertion handle was disconnected from the nail at the end of the case, it was discovered that the sleeve hadn't come out and was stuck.It was discovered that when the sleeve disengaged, it migrated south over the proximal portion of the nail.Three of the proximal screws were inserted through the sleeve & nail.The screws were backed out and the sleeve was removed, and then the screws reinserted.Procedure was completed successfully without any surgical delay.No patient consequences.This report is for one (1) 12.0mm outer protection sleeve for suprapatellar - sterile.This is report 1 of 5 for complaint (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: e1: initial reporter facility name and address added.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.D10: date of concomitant therapy is 7/18/2023.
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.H6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device image.Visual analysis of the photo revealed that the 12.0 outer protec slv suprapatellar -s had damage in the assembly base, it was observed broken, therefore, assembling issues are most likely due to this condition that caused the damage of 3 holes that are observed in the device.The reported condition can be confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for 12.0 outer protec slv suprapatellar -s.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 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): 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: 17454690
• Report Number: 8030965-2023-09800
• Device Sequence Number: 20655015
• Product Code: JDS
• UDI-Device Identifier: 10886982068781
• UDI-Public: (01)10886982068781
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,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 Catalogue Number: 03.010.437S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 09/14/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/22/2023; 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - NAILS; UNK - SCREWS: NAIL PROXIMAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING; UNK - SCREWS: NAIL PROXIMAL LOCKING
• Patient Sex: Unknown