MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ACF TRIAL SPACER/LORDOTIC 10MM; MISC ORTHO SURGICAL INSTR

Model Number	396.420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: the instrument was received at us cq.The device was received in three separate pieces; handle, pin and shaft.There is no fractures or evidence of breakage, instead the pin fell off allowing the handle to come off easily from the shaft.Although there is no breakage, the overall complaint is confirmed as the devices easily comes apart due to the pin becoming separate from the instrument.A device failure was identified.Functional test: a functional test was not performed as placing the pin back into the pin hole of the handle and shaft may resulting in damaging the instrument further, as per drawing 396-415 rev b note 2 it states ¿drill, ream and pin handle at assembly¿.Dimensional inspection: dimensional inspection was not performed due to conclusive finding of press fit failure resulting in the complaint condition.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) trial spacer, lordotic acf.Conclusion: the overall complaint was confirmed for the received instrument as the device comes apart due the press fit failing.Although no definitive root-cause can be determined, it is possible that the pin came undone and went missing through repetitive use/sterilization cycles over its life cycle (20+ years).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.A device history record (dhr) review was conducted: part #: 396.420.Synthes lot number: a4js398.Manufacturing site: synthes brandywine.Release to warehouse date: 21-apr-1999.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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 that on march 24, 2020 the acf trial spacer lordotic was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This report is for one (1) acf trial spacer/lordotic 10mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: ACF TRIAL SPACER/LORDOTIC 10MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9974176
• Report Number: 2939274-2020-01919
• Device Sequence Number: 2546830
• Product Code: LXH
• UDI-Device Identifier: 10705034777702
• UDI-Public: (01)10705034777702
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/24/2020

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: 396.420
• Device Catalogue Number: 396.420
• Device Lot Number: A4JS398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1