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 Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: hwc.Investigation summary: investigation flow: visual.Visual inspection: the ti sternal locking straight plate/13 holes/without pin (p/n: 460.046, lot number: 6861381) was received at us cq.Visual inspection of the complaint device showed the device was cut and not broken.The technique guide mentions to cut the device to the correct length for the patient.No other damage or defects were identified.Document/specification review: no design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as the device is cut but not broken.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 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 history lot: part number: 460.046, lot number: 6861381, part manufacture date: jan 20, 2012, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti sternal locking straight plate/13 holes/without pin product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.Raw material lot 5533982 was reworked, per f-s146, for the following reason: ¿bk100289 billets are conforming but due to no demand they will be reworked to the bk100322 by the approved supplier and re-inspected.¿ this rework produced new raw material lot number 6796008, which is the raw material the parts were manufactured from.This raw material lot (6796008) 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.Device history review: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that 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 on (b)(6) 2020, one (1) stepped drill bit cannulated did not function; six (6) depth gauge for locking screws, two (2) locking bolt measuring device, and one (1) titanium sternal locking straight plate were found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement.This report is for (1) ti sternal locking straight plate/13 holes/without pin.This is report 07 of 10 of (b)(4).

• 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: 9647726
• Report Number: 2939274-2020-00548
• Device Sequence Number: 14183763
• Product Code: HRS
• UDI-Device Identifier: 10887587055251
• UDI-Public: (01)10887587055251
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K093772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 6861381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1