MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CUTTING INSTRUMENT FOR DISTRACTION FOOTPLATES; INSTRUMENT,CUTTING,ORTHOPAEDIC

Model Number	03.500.014
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.A device history record review was performed: part number: 03.500.014 synthes lot number: t977019 release to warehouse date: 07-may-2012 manufacture site: (b)(4) part expiration date: n/a.A nonconformance report (nrc) was started because the parts did not pass the clinical reprocessing test.The parts were reworked (surface finish of the handles) and the parts were checked 100% and found to be good.The rework has no bearing to the complaint issue as the only the handles were reworked.This was one of the first lots produced of this device and a supplier corrective action report (scar) was started for the lot because of coating flaking off.The parts were reworked by the supplier and 11 from 16 sets of jaws were scrapped due to the damage caused by the rework.There is some documentation missing from the dhr (final inspection) and the last nine positions were not signed off of the copy that is currently archived.A ncr has been started to investigate further.Please return the device for a manufacturing evaluation.A nonconformance has been started to investigate the deviations in the dhr.Please return the device for a manufacturing evaluation.A product development investigation was performed for the subject device: cq investigation: at customer quality, the returned cutting instrument for distraction foot plates (part: 03.500.014, lot: t977019, mfg: 07-may-2012) was inspected and the complaint was confirmed.The following investigations were performed: broken, device interaction /functional: visual inspection: visual inspection performed at customer quality observed that the cutting edge of the device was slightly worn.No new malfunctions have been identified.However, the device was also sent for manufacturing site for further investigation.Functional test: functional test performed on the returned device at (b)(4) site observed that the broken screw portions contributed to loosening and will not cut condition of two jaws which confirms the reported compliant condition.The received condition agrees with the complaint description and the complaint was confirmed.The compliant condition was replicated at the manufacturing site and the complaint was confirmed.Drawing review: relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for the cutting instrument 03_500_014, jaw drawings 03_500_014 _1and 03_500_014 _2 and determined to be suitable for the intended design and application when used as recommended.Dimensional analysis performed on the returned device at the manufacture site confirmed that all the given dimensions of the device are within the specifications per the device drawings.Material review: a device history review was performed for the returned instrument¿s lot number and an ncr related to rework on handles and a scar related to device coating were identified for the given lot.Based on the dhr review it was determined that both the stated nc and scar are not related to dull complaint condition of the device jaws.However, it was also stated in dhr review that piece of dhr documentation could not be found during the review.Therefore, in addition to dhr review the device was also sent to manufacturing evaluation.Manufacture site investigation: investigation performed on the device at (b)(4) site observed that screw securing points of the central screw that holds the two jaws as broken.The broken elements led to loosening of two jaws which in turn contributed to will not cut condition when the cutter is in closed position.Additionally, the material review was performed on the given device at (b)(4) site and confirmed that the measured hardness (55.5 hrc) during the production was in the specification of 53-56 hrc.Based off the manufacturer investigation it is thus confirmed that material or material properties did not contribute to the given complaint condition.Conclusion: during the investigation, no product design or manufacturing issues/discrepancies were observed that may have contributed to the complaint condition.While no definitive root cause could be determined it is possible that 6+ years of consistent use and any unintended forces encountered by the device during usage or handling could have contributed to complaint condition.Therefore, 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 or Problem Description
It was reported that the cutting instrument for distraction footplates is only bending the plate, not cutting it.The sales consultant tested the cutters before the scheduled surgery on (b)(6) 2018.No patient or procedure involvement.Concomitant devices reported: unknown synthes footplate (part #: , lot #: , qty.1) this is report 1 of 1 for (b)(4).

• Brand Name: CUTTING INSTRUMENT FOR DISTRACTION FOOTPLATES
• Common Device Name: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7609403
• Report Number: 2939274-2018-52521
• Device Sequence Number: 2074111
• Product Code: HTZ
• UDI-Device Identifier: 10887587010342
• UDI-Public: (01)10887587010342
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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 Model Number: 03.500.014
• Device Catalogue Number: 03.500.014
• Device Lot Number: T977019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1