MAUDE Adverse Event Report: SYNTHES GMBH 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.124.413

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(b)(4).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.Procode: additional pro-code: hwc, hrs.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation is a j&j sales representative.Product was not returned.Based on the information available, 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

It was reported that on unknown date, an event occurred where we did a nail plate combo, the first plate was used the central fixed angle screw hole did not lock into the plate, we ended up taking out the plate and using a second one of a longer length.We assembled the nail and then inserted the lm / ml screw holes and the drill bit missed the nail, i¿m not entirely sure if it was due to the notch of the tka replacement or because of the screws from the plate diverging the drill bit.The 13mm sleeve was bent during the case as well from pushing and the entry reamer was stuck in the sleeve.(b)(4) is related to (b)(4).(b)(4) captures post-op.(b)(4) captures intra-op.This complain involves five (5) devices.This report is for one (1) 4.5 va-lcp crvd cond pl/12 hole/266/lft this is report 4 of 5 for complaint (b)(4).

• Brand Name: 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• 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: 16250628
• MDR Text Key: 308712608
• Report Number: 8030965-2023-01031
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.413
• Device Catalogue Number: 02.124.413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.5 VA-LCP CRVD COND PL/12 HOLE/266/LFT; AIMING ARM RADIOLUCENT; CONNECTING SCREW; INSERTION HANDLE RADIOLUCENT