MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN; PLATE, FIXATION, BONE

Model Number	460.046
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: initial reporter is synthes sales representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.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) 2018, the patient underwent a hardware removal procedure of two (2) titanium sternal locking straight plates and twenty-three (23) unknown screws due to nonunion and broken plates.It was noted that the plates and screws came out of the patient.Initially, the patient had an open reduction internal fixation procedure (orif) with implantation of the plates and unknown screws on (b)(6) 2015, to repair an external fracture.It is unknown if there were fragments from the broken devices.Patient and procedure outcome are unknown.Concomitant reported devices: unknown screws (part # unknown, lot number#, quantity: 23).This report is for one (1) ti sternal locking straight plate/13 holes/without pin.This is report 2 of 2 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.Additional device product code: hwc.Device history records review was completed for part: 460.046, lot: 7387362.Manufacturing location: elmira, manufacturing date: may 21, 2013.A review of the device history record (dhr) revealed no non-conformances.This lot was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This 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.A review of the raw material dhr revealed this lot met all specifications with no complaint related non-conformances or rework noted.Product investigation was completed.Visual inspection observed that the titanium locking straight plate (460.046, 7387362) was broken into two fragments, one with 4 holes and the latter with 9 holes.The fracture surface appears homogenous with no voids, dark spots, or other irregularities in the metal.Very minor surface wear in the anodization of the titanium was observed, consistent with the age of the device (5+ years).The received condition of the device was determined to agree with the complaint description.No definitive root cause of the issue could be determined at this stage of the investigation.During the document/specification review the relevant drawings, reflecting the current and manufactured revision, were reviewed.All measurements performed with calipers ca802 met specifications.The complaint condition was confirmed as the 13 hole titanium sternal locking straight plate (460.046, 7387362) was determined to be broken through visual inspection.No new product design issues or manufacturing discrepancies were identified during this investigation.Based upon the investigation findings, no additional 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.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: TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN
• 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: 8249394
• Report Number: 2939274-2019-55861
• Device Sequence Number: 13842328
• Product Code: HRS
• UDI-Device Identifier: 10887587055251
• UDI-Public: (01)10887587055251
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K093772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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: 460.046
• Device Catalogue Number: 460.046
• Device Lot Number: 7387362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR