MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 150 DEG DHS® PLATE-STANDARD BARREL 5 HOLES/94MM; APPLIANCE,FIXATION,NAIL

Model Number	281.450
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device deemed reportable during investigation on (b)(6) 2020.Additional code: jdo.Investigation summary: visual inspection: dhs 150° 5ho l98 standard barrel sst was received at us cq.Upon visual inspection at cq, it is observed that there were scratches at few spots on the surface of the device and there is a dent on the edge of the drill hole.But no foreign substance was noticed on the surface of the device.Defect identified/ device failure? yes.The dent is consistent with attempted use and impaction on the lateral hole edge.Document/ specification review: the following relevant drawings were reviewed during investigation: pz dhs-plate-grinding 135 degree-150 degree.No design issues were found which can contribute to this complaint condition.Dimensional inspection: dimensional inspection of the received device was not performed as it is not relevant to the complaint condition of scratched/ nicked.Complaint confirmed? yes.But reported foreign substance condition cannot be confirmed.Investigation conclusion: a visual inspection, and document/specification review were performed as part of this investigation.The complaint is being confirmed as the device shows few scratched spots.Rough handling during sterilization and storage or transportation in the field might have contributed to the complaint condition.It cannot be determined when the dent occurred but is most likely that the customer attempted to use the device and replaced it in the set.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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: part number: 281.450.Lot number: 5742057.Part manufacturing date: 27 march 2008.Manufacturing site: elmira.Part expiration date: n/a.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 5742057 of 150 degree dhs plates was processed through the normal manufacturing and inspection operations with no rework or nonconformance's 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 device history record(s) determined the raw material lot 5247540 met all specifications with no issues documented 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
Device report from synthes reports an event in (b)(6) as follows: it was reported during inspection of two (2) dynamic hip screw (dhs) loaner implant sets to the hospital, the processing department noticed there is damage on one flat side of each dhs barrel plate.After two (2) additional washes/sterilization, the damage was still there.Upon closer inspection, it looks like they have been scratched or etched.No patient involvement.This is report 1 of 2 for (b)(4).This complaint is linked to (b)(4) and (b)(4).

• Brand Name: 150 DEG DHS® PLATE-STANDARD BARREL 5 HOLES/94MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9980802
• Report Number: 2939274-2020-01941
• Device Sequence Number: 4483548
• Product Code: KTT
• UDI-Device Identifier: 10886982177384
• UDI-Public: (01)10886982177384
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2020

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: 281.450
• Device Catalogue Number: 281.45
• Device Lot Number: 5742057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1