MAUDE Adverse Event Report: HAGENDORF SYNTHES PRODUKTIONS GMBH CONNECSCR CANN MED; ORTHOPAEDIC INSTRUMENT SURGICAL CONNECTOR

Catalog Number	03.043.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer 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
Device report from depuy synthes reports an event in (b)(6) as follows: this is report 1 of 3 for (b)(4).It was reported by the sales rep in (b)(6) that on (b)(6) 2022, the patient underwent the osteosynthesis surgery for the tibial shaft bone fracture with the connecting screw device.It was reported that the drill collided the nail hole and that possibility of the connecting screw deformation was confirmed.According to the report, the drill collided in the distal ml1 hole of the tibial nail advanced nail.It was reported that the drill was in contact with the posterior side of the hole.It was reported that the knee was moved in a flexed position, and a screw was inserted first from the distal ml 2 hole.It was reported that the surgeon went back to the distal ml 1-hole procedure, where the surgeon manually manipulated the protection sleeve to point it forward before performing the procedure, and somehow managed to insert the screw.It was reported that although it was difficult to insert the screw into the distal ml1 hole as described above, the surgeon had been careful not to loosen the connecting screw during the surgery.The surgery was completed successfully without any surgical delay.There were no adverse patient consequences reported.It was reported that after the surgery, the surgeon commented that although the procedure was performed with a parapatellar approach and performed with mild flexion of the knee, it was assumed highly likely that the drill interfered during inserting the screw to distal ml1 because bending and distortion occurred due to the femur applied pressure to the nail due to insufficient flexion of the knee was insufficient.No additional information was provided.This report is for one (1) connecscr cann med device.This complaint involves three (3) devices.
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: part 03.043.022, lot 76p2996: manufacturing site: haegendorf.Release to warehouse date: november 23, 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed that the connection screw was deformed from the shaft.Alignment issues are most likely due to this condition.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was performed using a gauge pin; it did not advance smoothly, confirming the deformation of the shaft.An interaction test was not performed since the mating device was not returned.The complaint condition was able to be replicated.The drawings reflecting the current and manufactured revisions were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.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: CONNECSCR CANN MED
• Common Device Name: ORTHOPAEDIC INSTRUMENT SURGICAL CONNECTOR
• Manufacturer (Section D): HAGENDORF SYNTHES PRODUKTIONS GMBH; im bifang 6; hagendorf 4614 ; SZ 4614
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14240651
• Report Number: 8030965-2022-02783
• Device Sequence Number: 17327527
• Product Code: HWC
• UDI-Device Identifier: 07612334171030
• UDI-Public: 07612334171030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: 03.043.022
• Device Lot Number: 76P2996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: TRAUMA; UNK - NAILS: TIBIAL; UNK - SCREWS
• Patient Sex: Unknown