MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LOW PROFILE TRANSCONNECTOR 42MM-55MM FOR 6.0MM RODS; ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION

Model Number	497.798
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part number: 497.798, lot number: 6321202, part manufacture date: 09 feb 2010, manufacturing location: elmira, 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 low profile transconnector 42mm-55mm for 6.0mm rods was processed through the normal manufacturing and inspection operations with no non-conformance's or rework noted.The lot quantity of 24 pieces 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.Assembly components: 497.796.04 cap screw, 2.5mm hex socket lot 6202569 24 pcs, 497.796.05 set scr, m5x0.5, 6mm rod clamp lot 6202566 11 pcs, 497.796.05 set scr, m5x0.5, 6mm rod clamp lot 6202567 37 pcs, 497.796.7 m5 set screw-transconnector lot 6182436 24 pcs, 497.796.03 transconnector body, link end lot 6317240 22 pcs, 497.798.01 transconnector body female lot 6294228 13 pcs, 497.798.01 transconnector body female lot 6292467 11, 497.798.2 intermediate link lot 6308719 24 pcs.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows the above products were processed through the normal manufacturing and inspection operations.The final lot quantities 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.497.796.03 transconnector body, link end lot 6310974 2 pcs.Lot 6310974 was found with cosmetic anomalies for 14 of 44 pieces with marks on top side.13 pieces w lot met all dimensional, visual and packaging criteria at the time of release.Ere reworked per approved rework process, 1 pc determined conforming upon review by quality engineer.This lot met all dimensional, visual and packaging criteria at the time of release.Part number: bk100357, lot number: 6295819, part manufacture date: 01 jan 2010, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.A review of the device history record for the raw material 17mm round x 400mm long ti revealed no complaint related anomalies the device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Part number: bk100357, lot number: 6285838, part manufacture date: 15 dec 2009, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.A review of the device history record for the raw material 17mm round x 400mm long ti revealed no complaint related anomalies the device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Part number: tialnbri6.00, lot number: 5264310, part manufacture date: 15 jul 2008, manufacturing location: elmira, part expiration date: n/a.Nonconformance noted: nr us1002551 was issued for dimensional features length and outside diameter of the raw material bar stock.The product was accepted as "use as is" per nc disposition.This non conformance has no impact or effect on the finished product.A review of the device history record for the raw material tialnbri6_00 revealed no complaint related anomalies the device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the ti low profile transconnector 42mm-55mm for 6.0mm rods (p/n: 497.798, lot number: 6321202) was received at us customer quality (cq).Visual inspection of the complaint device showed that two set screws were missing, and the device could fall apart since it was loose.The device does not fall apart because the set screws are missing.Functional test: the complaint device falls apart when put together, despite the note on drawing which says the ¿items must be free to slide but cannot come free¿.The complaint was able to be replicated.Dimensional inspection: conforming.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device falls apart and is missing two set screws.No root cause could definitively be determined for the reported complaint condition.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 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) 2019 a titanium low profile transconnector did not function during the reverse logistics audit of returned devices at millstone.There was no patient involvement and no additional information is available.Tpc-report is for one ti low profile transconnector 42mm-55mm for 6.0mm rods.This is report 1 of 1 for (b)(4).

• Brand Name: TI LOW PROFILE TRANSCONNECTOR 42MM-55MM FOR 6.0MM RODS
• Common Device Name: ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9719820
• Report Number: 2939274-2020-00883
• Device Sequence Number: 2353298
• Product Code: MNH
• UDI-Device Identifier: 10705034788432
• UDI-Public: (01)10705034788432
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K992739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: 497.798
• Device Catalogue Number: 497.798
• Device Lot Number: 6321202
• 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: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1