MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PUSH-PULL REDUCTION DEVICE; GUIDE

Catalog Number	324.024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient id, age, dob & weight not available for reporting.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Device history records review was conducted.The report indicates that the: part # 324.024, synthes lot # 4548848, supplier lot # (b)(4), release to warehouse date: 20 dec 2003.Supplier: (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Ncr's were generated during production.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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
It was reported that during initial open reduction internal fixation procedure for proximal humerus, push-pull reduction device broke into 2 pieces.There were unknown minutes of delay to retrieve fragments from the patient's bone and switch to new instrument.Procedure was completed successfully.Patient outcome is unknown.This complaint involves one device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Date reported incorrectly on the previous follow-up medwatch (b)(4).The date should have been april 5, 2018.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.
Additional Manufacturer Narrative
A product investigation was performed.The 324.024 push-pull reduction device is a reusable instrument available for use in several systems.The device is self drilling/self-tapping and can be used to temporarily compress a plate to bone and assist in bone fragment reduction to the plate.The device should be inserted into the near cortex only and can be done under power if desired using the proximal synthes quick coupling connection.After power insertion, the collet is turned clockwise until it compresses the plate securely to the bone.Care should be taken when inserting the device into a hole that will be needed for plate fixation.After the device is removed, a conventional screw can be placed in the same hole.This complaint is confirmed.The returned 14+ year old instrument was received at customer quality (cq) in three (3) pieces.The drill shaft component is broken in two pieces.The break is slightly oblique and occurred at the transition between distal thread and solid shaft.The knob component was also returned.Whether this complaint can be replicated at cq via functional test is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.Push-pull reduction device assembly drawing and drill shaft component drawing were reviewed during this investigation.No product design issues or discrepancies were observed.The diameter of the shaft near location of breakage for the returned device was measured at cq and is within specification per drill shaft component drawing.The material and relevant material properties including material hardness were determined to be conforming at the time of manufacture based on review of the dhr.The slightly oblique shaft fracture on the returned 14+ year old reusable instrument suggests that an off-axis force contributed to the breakage.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.

• Brand Name: PUSH-PULL REDUCTION DEVICE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7299300
• Report Number: 2939274-2018-50794
• Device Sequence Number: 1994044
• Product Code: FZX
• UDI-Device Identifier: 10886982190963
• UDI-Public: (01)10886982190963(10)26355
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2018

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: 324.024
• Device Lot Number: 26355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 02/22/2018; 04/19/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/18/2018; 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1