MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 130 DEG ANGLED BLADE PL 12 HOLES/90/200; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Model Number	238.28
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent a revision surgery for a subtrochanteric fracture.A 130-degree angled blade plate was implanted during the surgery.At some point before the alert date, the plate broke.The surgery to remove the broken plate took place on (b)(6) 2021.There was a non-union and plate breakage.The procedure and patient outcome were unknown.This report is for one (1) 130 deg angled blade pl 12 holes/90/200.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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.H10 additional narrative: d10: date of concomitant therapy is october 8, 2021.H3, h4, h6: part: 238.280-us.Lot: 1l75859.Release to warehouse date: november 22, 2018 manufactured by: werk grenchen a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the130 deg angled blade pl 12 holes/90/200 was received at us customer quality (cq).Upon visual inspection, the plate was found to be broken.The broken piece was also returned.No other issues were identified.Dimensional inspection: the dimensional inspection was not performed due to the post manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the plate has broken off.No definitive root cause could be determined based on the provided information.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.G1.

• Brand Name: 130 DEG ANGLED BLADE PL 12 HOLES/90/200
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12977826
• Report Number: 2939274-2021-07044
• Device Sequence Number: 14631475
• Product Code: KTW
• UDI-Device Identifier: 10886982161697
• UDI-Public: (01)10886982161697
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K914546
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2021

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: 238.28
• Device Catalogue Number: 238.28
• Device Lot Number: 1L75859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female