MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI STERNAL LOCKING STAR PLATE- 12 HOLES; PLATE, FIXATION, BONE

Model Number	460.036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro-codes: hwc, jdq.Device available for evaluation: device returned.A review of the device history record has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; 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 the patient underwent a hardware removal on an unknown date of the titanium (ti) locking sternal locking manubrium plates with an unknown issue.Procedure outcome and patient status are unknown.Concomitant medical product: unk - screws: (part# unknown; lot# unknown; quantity: unknown) this complaint involves one (1) device.This report is 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.H10 additional narrative: b5; d4; d11; e1.H6: added patient codes.H6: patient code 3191 used to capture additional medical/surgical intervention required.H3, h6: a product investigation was conducted.Visual inspection: the ti sternal locking star-plate -12 holes (p/n: 460.036, lot #: 13l3774) was returned and received at us cq.Upon visual inspection, it was observed that the 12 hole tab was broken.There were scratches consistent to explantation and have no impact on the functionality of the device.No other defects were identified with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the ti sternal locking star-plate -12 holes (p/n: 460.036, lot #: 13l3774).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part number: 460.036.Lot number: 13l3774.Per jde, manufactured date: 08/01/2019.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.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 the patient underwent the hardware removal procedure on (b)(6) 2020 to remove the star plate due to non-union.The plate was broken once surgeon got in.The plate was removed successfully, area was washed out, no additional rigid fixation, soft tissue closure.There was a delayed healing but none had some gap during initial plating, not completely reduced when plate was first put in.Procedure was successfully completed.Patient status is unknown.Patient was implanted with plate and screws approximately 2 months ago.

• Brand Name: TI STERNAL LOCKING STAR 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: 9752024
• Report Number: 2939274-2020-01051
• Device Sequence Number: 19014536
• Product Code: HRS
• UDI-Device Identifier: 10887587055121
• UDI-Public: (01)10887587055121
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K010943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2020

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: 460.036
• Device Catalogue Number: 460.036
• Device Lot Number: 13L3774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention