MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM; PLATE,FIXATION,BONE

Model Number	241.381
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.
Event or Problem Description
It was reported that on (b)(6) 2020, during an ankle reconstruction procedure, an unknown locking screw fell through the locking compression plate (lcp) one-third tubular plate hole when the surgeon was tightening the locking screw.The procedure was successfully completed using another plate with a five (5) minute surgical delay.No patient consequences reported.Concomitant device reported: unknown locking screw (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.This is 1 of 1 for report (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part: 241.381; lot: 29p6036; part manufacture date: december 10, 2019; manufacturing location: elmira.Part expiration date: n/a.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of lcp one-third tubular plate with collar 8 holes/93mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection as received condition of device: one piece of part number 241.381-us, batch/lot 29p6036 was received loose in a bag without its packaging.The part is laser etched with the synthes logo, 241.381, and 29p6036.A visual inspection of the lcp one-third tubular plate revealed cosmetic signs of handling consistent with implantation consisting of light scratches to the surface finish.Functional testing could not be performed, as the mating device was not returned.Dimensional inspection features relevant to the complaint condition and to the identification of the part were inspected for part number 241.381-us, batch/lot 29p6036 per document final inspection sheet for part number 241.381-us.W1 (centering): result: pass.W (width): result: pass.D1 (thread pitch diameter depth (8x)): results: (1) fail; (2) pass; (3) fail; (4) fail; (5) fail; (6) fail; (7) fail; (8) fail.L1 (wall thickness both ends): results: (1) nogo (fail); (2) nogo (fail); t (thickness); result: fail.D (90 degree countersink (8x)): results: (1) pass; (2) pass; (3) pass; (4) pass; (5) pass; (6) pass; (7) pass; (8) pass.D2 (thread minor diameter depth (8x)): results: (1) could not be obtained - oversized; (2) could not be obtained - oversized; (3) could not be obtained - oversized; (4) could not be obtained - oversized; (5) could not be obtained - oversized; (6) could not be obtained - oversized; (7) could not be obtained - oversized; (8) could not be obtained ¿ oversized.Document/specification review: engineering drawing.Inspection sheet: no relevant design issues were observed during investigation.Conclusion: the complaint was confirmed during investigation as the device did not meet multiple dimensional specifications, which could lead to the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/93MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9849947
• Report Number: 2939274-2020-01330
• Device Sequence Number: 740799
• Product Code: HRS
• UDI-Device Identifier: 10886982166913
• UDI-Public: (01)10886982166913
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 241.381
• Device Catalogue Number: 241.381
• Device Lot Number: 29P6036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LCP ONE-TRD TBLR PLT W/ COLR 8 HOLES/93MM; UNK - SCREWS: LOCKING