MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

Model Number 03.231.007

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Additional pro codes: hrs, hwc.Device is an instrument and is not implanted/explanted.Part: 03.231.007; lot: 7886292; manufacturing site: (b)(4); release to warehouse date: may 03, 2012.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.Only top level of the device history record reviewed as sub-components are not lot tracked.Therefore, a review of the material is not possible.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.Investigation flow: broken.Visual inspection: the locking/neutral guide was returned to us customer quality with a broken weld that connected the guide sleeve and sleeve body together.The two subcomponents were returned disconnected.Minor surface wear and tear was observed, which would not contribute to the complaint condition.No new malfunctions were identified.Based on the visual inspection, the returned condition agrees with the event description, therefore the complaint is confirmed.Dimensional inspection: dimensional analysis was performed proximal to the breakage area.The proximal outer diameter of the guide sleeve was measured at ø10.98mm, which is within specifications of ø11 -/+ 0.2mm.The inner diameter of the sleeve body measured at ø10.99mm, which is within specifications of ø10.98mm and ø11.18mm.Document/specification review: 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.Material/hardness review was not performed as only top level of the device reviewed as sub-components are not lot tracked.The following drawing(s) was reviewed: top level drawing of guide sleeve asm; body; guide sleeve.Conclusion: while no definitive root cause could be determined, it is possible that the device encountered unintended forces that could contribute to the complaint condition of the weld breaking.Therefore, the complaint condition is confirmed.During the investigation, no product design issues or manufacturing discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 during distal femur procedure on (b)(6) 2018, two (2) interlocking bolts, one (1) 4.5mm variable angle locking compression plate (va-lcp) curved condylar plate and one (1) locking/neutral guide for 4.5mm va lcp curved condylar aiming arm was damaged.While assembling va-lcp curved condylar plate on the insertion handle for percutaneous aiming arm, the va-lcp locking hole became stripped.After inspection, another plate was assembled and implanted.Procedure was successfully completed.It is not known if there was a surgical delay related to the reported event.Patient outcome was unknown.Concomitant device: insertion handle (part: unknown, lot: unknown, quantity: unknown).This report is for a lock/neutral guide for 4.5mm va lcp curved condylar aiming arm.This is report 1 of 2 for (b)(4).

• Brand Name: LOCK/NEUTRAL GUIDE F/4.5MM VA LCP CRVD CONDYLAR AIMING ARM
• Type of Device: IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7874895
• MDR Text Key: 120701419
• Report Number: 2939274-2018-53763
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982077349
• UDI-Public: (01)10886982077349
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.231.007
• Device Catalogue Number: 03.231.007
• Device Lot Number: 7886292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1