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(b)(4).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.
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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.H10 additional narrative: d11: concomitant product added to complaint.Investigation summary background: 12/15/2020: updated event description: it was reported that on an unknown date, the barrel plate wouldn¿t seat over blade and both impactor cap tip broke in the process.I¿m not sure which one was at fault so i will give you the numbers for them all.Nothing was left in the patient.Ended up removing everything and using cannulated screws.The procedure was successfully completed with an unknown number of surgical delay.The patient outcome is unknown.This complaint involves five (5) devices.H3, h4, h6: device history lot.Manufacturing location: supplier ¿ troutman industries / inspected, packaged and released by: (b)(6).Release to warehouse date: (b)(6) 2017.Part number: 338.348, lcp dhhs ¿ impactor cap.Lot number: h508931 (non-sterile).Lot quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Certificate of compliance supplied by troutman industries dated (b)(6)2018 was reviewed and determined to be conforming.Quality performance sheet supplied by troutman dated (b)(6)2017 was reviewed and determined to be conforming.Declaration of conformance supplied to troutman by quadrant industries for raw material dated (b)(6)2017 was reviewed and determined to be conforming.Certificate of compliance supplied to troutman by fischer laser marking dated (b)(6)2018 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, (b)(6) rev e met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev c was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device history batch null, device history review (b)(6)2020: dhr reviewed.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.H6: investigation flow: damage visual inspection: the lcp dhhs (tm) impactor cap (p/n: 338.348, lot #: h508931) was returned and received at us cq.Upon visual inspection, it was observed that the cap was broken and the broken fragments were not returned.No other issues were observed with the returned device.Device failure/defect was identified.Dimensional inspection: the outer diameter of the impactor cap close to the broken part was measured and is within specification.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed impactor cap: 338_348, rev.D/c.Lcp dynamic helical hip system (dhhs) surgical technique: dsus/trm/1215/0781(1) 6/17 dv.Complaint was confirmed.The device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the lcp dhhs (tm) impactor cap (p/n:(b)(6), lot #: h508931).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the impactor cap.The surgical technique states not to use impactor cap and shaft to seat the plate if the plate is more than 5mm off the bone as it the flats on the helix blade and the internal flats on the key may not be properly aligned which could cause further unwanted advancement of the helix blade.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 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.
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