MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI VAL STRAIGHT PLATE 12 HOLES; PLATE,FIXATION,BONE

Model Number	04.130.351
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an unknown date, the patient underwent an unknown procedure.Upon insertion of lupine, the variable angle locking plate was busted.Fragments were generated from the broken device and were removed.A new implant was opened and was drilled in a different spot.The procedure was successfully completed with seven (7) minutes of surgical delay.The patient's status is unknown.This complaint involves one (1) device.This report is for one (1) 2.0 mm ti val straight plate 12 holes.This is report 1 of 1 for (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.Patient code 3191 used to capture additional info: surgical intervention 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
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: b5: updated event description provided for reporting.H3, h4, h6: a review of the device history record.Device history lot.Part: 04.130.351.Lot: 2l08221.Manufacturing site: grenchen.Release to warehouse date: (b)(6)2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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)2019: updated event description: it was reported that on an unknown date, the patient underwent an unknown procedure.Upon insertion of lupine, the variable angle locking plate was busted.A new implant was opened and was drilled in a different spot.Fragments were generated from the broken device but were removed easily without additional intervention.The procedure was successfully completed with seven (7) minutes of surgical delay.The patient's status is unknown.This complaint involves one (1) device.

• Brand Name: 2.0MM TI VAL STRAIGHT PLATE 12 HOLES
• 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: 9188866
• Report Number: 2939274-2019-61530
• Device Sequence Number: 3447933
• Product Code: HRS
• UDI-Device Identifier: 10886982113443
• UDI-Public: (01)10886982113443
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K150099
• 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,Followup
• Report Date (Section B): 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.130.351
• Device Catalogue Number: 04.130.351
• Device Lot Number: 2L08221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/14/2019; 10/25/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 10/14/2019; 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention