MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE COUPLING SCREW; MISC ORTHO SURGICAL INSTR

Catalog Number	357.377
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided for reporting.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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
(b)(6) reports following: it was reported that on (b)(6) 2018, patient underwent a titanium trochanteric fixation nail system (tfn) procedure.During the procedure, after the insertion of the helical blade, the helical blade coupling screw head snapped off while trying to unthread from the blade.The coupling screw was left attached to the helical blade within the helical blade inserter and could not be removed.The surgeon attempted to unthread the screw but could not get a sufficient hold as the shaft of the coupling screw was sunken into the impaction handle.The taper of the coupling screw made it impossible to remove the impaction handle to unthread the coupling screw.Eventually, the surgeon could only back off the coupling screw with mallet strikes.While successful in disengaging the coupling screw this left the helix blade impactor heavily damaged.The process delayed surgery by 40 minutes and there were no further complications during the surgery and completed without further incident.Concomitant devices reported: helical blade (part # unknown, lot # unknown, quantity 1), mallet (part # unknown, lot # unknown, quantity 1).This report is for one (1) helical blade coupling screw.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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
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.Part: 357.377; synthes lot: 6014273; supplier lot: is10065; release to warehouse date: november 03, 2008; supplier: (b)(4).The material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.No nonconformance reports (ncr's) were generated during production.Review of the device history record(s) (dhr) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation flow: broken visual inspection: the complaint device was received at us cq in two pieces.The break in the shaft of the device was immediately distal to the shaft/cap interface.The break on the cap end was convex and the break on the shaft end was concave, indicating that it is likely the device broke due to excessive tensile forces.Heavy impaction marks and numerous gouges were observed on the top surface of the cap.Deformation was noted on the inner hex feature at the proximal end of the shaft, which remained in the cap.The distal end of the shaft had circumferential discoloration marks.The received condition of the device agrees with the complaint condition.Thus, the complaint is confirmed.Document/specification review: in addition to the dhr, the following documents were reviewed as part of the investigation: helical blade coupling screw ¿ trochanteric fixation nail.Shaft ¿ helical blade coupling screw.Per the dhr review, the material hardness was within specification at the time of manufacture.No manufacturing defects were identified.The changes between drawings (manufactured revision and current revision) for helical blade coupling screw ¿ trochanteric fixation are related to etch contents and location.Therefore, these changes are not relevant to the complaint condition.The changes between drawing (manufactured revision and current revision) for shaft ¿ helical blade coupling screw are related to the removal of inspection dimension bubbles and adding tolerances to the angle dimensions in the drawing.These changes are not related to either the inner or outer diameter dimensions of the shaft and are therefore not relevant to the complaint condition.No product design issues were identified during the investigation.Dimensional inspection: the relevant dimensions to the complaint condition are the inner diameter (id) and outer diameter (od) of the shaft at the proximal end of the shaft.Per drawing, the design id in this location is ø 3.6 mm +0.2/-0.1 mm.The id was measured with gage pin gp32 and found to be 3.77 mm.This result is within the design specification.Per drawing, the design od in this location is ø 6.1 mm ± 0.1 mm.The od was measured with micrometer om800 and found to be 6.108 mm.This result is within the design specification.Conclusion: a visual inspection, document/specification review and dimensional inspection were performed as part of this investigation.The complaint condition was confirmed, as the cap of the coupling screw was broken off the shaft.While no definitive root cause could be determined, the complaint device has been in the field for 9+ years and it is possible that unintended off-axis forces encountered by the device over this time could have contributed to the complaint condition.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these findings, 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: HELICAL BLADE COUPLING SCREW
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7781905
• Report Number: 2939274-2018-53320
• Device Sequence Number: 13800933
• Product Code: LXH
• UDI-Device Identifier: 10886982196088
• UDI-Public: (01)10886982196088
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2018

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: 357.377
• Device Lot Number: IS10065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/22/2018; 09/19/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 09/18/2018; 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1