MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/LT-STER; PLATE, FIXATION, BONE

Model Number 02.124.413S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is company representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) 2020, during an unknown procedure, the threaded guide was not drilling to the guide.The surgeon used a different variable angle locking compression plate/12 hole/266 mm/left.The tip of the flexible shaft and stardrive screwdriver shaft was bent and the medullary reamer head was broke inside the patient.The fragments from the device were broken in the patient, surgery was delayed roughly about twenty to thirty (20-30) minutes.The procedure was successfully completed.This is report 1 of 4 for (b)(4).

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.Investigation flow: damage and device interaction/ functional.Visual inspection: the 4.5mm va-lcp curved condylar plate/12hole/266mm/lt-ster (part #: 02.124.413sand lot #: 2l51507) was received showing deformed threads in the first variable angle combi hole.No other issues were identified with the returned components of the device.The complaint condition could be confirmed.Functional test: a functional test cannot be performed as the 4.5mm va-lcp curved condylar plate/12hole/266mm/lt-ster was returned by itself.Can the complaint be replicated with the returned devices? unable to perform as the 4.5mm va-lcp curved condylar plate/12hole/266mm/lt-ster was returned by itself.However, the condition of the deformed thread could have caused the complaint condition.Dimensional inspection: dimensional inspection cannot be performed for threads due to the geometry of the device.Document/specification review: all relevant drawings are reflecting the manufactured and current revision, were reviewed.Complaint confirmed? yes.Investigation conclusion: the complaint condition is confirmed for the viper2 t20 hexlobe driver shaf (part #: 286725020 and lot #: ag2098246).There is no indication that a design or manufacturing issue has caused the issue 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 history lot part number: 02.124.413s, lot number: 2l51507, manufacturing site: mezzovico, release to warehouse date: dec.14, 2018, expiry date: dec.01, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12HOLE/266MM/LT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10621395
• MDR Text Key: 209636349
• Report Number: 2939274-2020-04458
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982042880
• UDI-Public: (01)10886982042880
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.124.413S
• Device Catalogue Number: 02.124.413S
• Device Lot Number: 2L51507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 10/19/2020
• Patient Sequence Number: 1
• Treatment: 12.0MM MEDULLARY REAMER HEAD; 5.0MM FLEXIBLE SHAFT 620MM; STARDRIVE SCREWDRIVER SHAFT T8 55MM; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING; 12.0MM MEDULLARY REAMER HEAD; 5.0MM FLEXIBLE SHAFT 620MM; STARDRIVE SCREWDRIVER SHAFT T8 55MM; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - GUIDES/SLEEVES/AIMING