MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/18HOLE/370MM/LT-STER; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.419S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

510k: this report is for an unknown 4.5mm va lcp condylar plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes sales consultant.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during an unknown surgical procedure on (b)(6) 2018, the interlocking bolt for 4.5mm variable angle locking compression plate (va-lcp) condylar insertion handle pulled off the plate.The jig was assembled and inserted per the surgical technique and the plate was fixed distally with wires and the aiming arm was attached.An incision was made for the proximal wire guide but as the sleeve and trocar were inserted, the jig and aiming arm came off the plate.Surgeon attempted to reconnect with the interlocking bolt appearing to grip each time but as the surgeon attempted to tighten the nut, the interlocking bolt would pull off the plate.Surgeon visually inspected both the plate and the interlocking bolt but could not see any obvious cause.Surgery was completed with a 10 minute delay using x-ray to guide the minimally invasive surgical (mis) incisions.Visual inspection of the interlocking bolt after the procedure revealed the threads are slightly worn.The plate remains implanted.This report is for one (1) unknown 4.5mm va lcp condylar plate.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

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 Description

Further it was reported that the operation was completed successfully using a normal drill guide with x-ray to guide minimally invasive surgical (mis) incisions or mis approach.

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.Part: 02.124.419s; lot: l727872; manufacturing site: mezzovico; release to warehouse date: february 05, 2018; expiry date: january 01, 2028 the device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The manufacturing documents were reviewed and no complaint related issues were found.Product was not returned, therefore no further investigation is possible.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 Description

This report is for a 4.5mm va-lcp curved condylar plate.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/18HOLE/370MM/LT-STER
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7997931
• MDR Text Key: 124816529
• Report Number: 8030965-2018-57560
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.419S
• Device Lot Number: L727872
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Patient Sequence Number: 1