MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ANGL-BLADEPL 130° 6HO L104 BLADE80 SST; PLATE,FIXATION,BONE

Model Number	238.66
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the provided patient x-ray.Examination of the provided x-ray has found the reported plate has broken near the proximal portion.The investigation has found sufficient evidence to confirm the reported event.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed.And a dimensional inspection document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part #: 238.660-us, synthes lot #: l355473, release to warehouse date: 31 mar 2017, manufactured by: grenchen.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this 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.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent an orthopedic procedure.This was a non union proximal femur osteotomy fixed with synthes 130 degree blade plate.It was noted that the plate was broken due to non union.There was an unknown surgical delay.It was unknown if the procedure was completed.Patient status is unknown.There is no further information available.This report is for one (1) angl-bladepl 130° 6ho l104 blade80 sst.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the provided patient x-ray.Examination of the provided x-ray has found the reported plate has broken near the proximal portion.The investigation has found sufficient evidence to confirm the reported event.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed.And a dimensional inspection document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part #: 238.660-us, synthes lot #: l355473, release to warehouse date: 31 mar 2017, manufactured by: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this 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.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent an orthopedic procedure.This was a non union proximal femur osteotomy fixed with synthes 130 degree blade plate.It was noted that the plate was broken due to non union.There was an unknown surgical delay.It was unknown if the procedure was completed.Patient status is unknown.There is no further information available.This report is for one (1) angl-bladepl 130° 6ho l104 blade80 sst.This is report 1 of 1 for (b)(4).

• Brand Name: ANGL-BLADEPL 130° 6HO L104 BLADE80 SST
• Common Device Name: PLATE,FIXATION,BONE
• 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 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12977155
• Report Number: 2939274-2021-07036
• Device Sequence Number: 4647258
• Product Code: HRS
• UDI-Device Identifier: 10886982161994
• UDI-Public: 10886982161994
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2021

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: 238.66
• Device Catalogue Number: 238.660-US
• Device Lot Number: L355473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• 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 Age: 61 YR
• Patient Sex: Male