MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.632.037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was reported.Device is an instrument and is not implanted/explanted.Initial reporter is synthes sales consultant.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 during a field inventory inspection on (b)(6) 2018, a polyaxial head placement tool was found broken.There was no patient involvement.This report is for one (1) polyaxial head placement tool for matrix.This is report 1 of 1 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.A device history record (dhr) review was conducted for part number: 03.632.037, synthes lot number: 6678668, supplier lot number: n/a: release to warehouse date: 30-nov-2011, expiration date: n/a, supplier: magnum manufacturing center: no non-conformance reports (ncrs) were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product investigation was conducted.Background: the polyaxial head placement tool (03.632.037) is used in the matrix degenerative and deformity spine systems.The tool is used to retrieve a polyaxial head from an implant module and place it over a matrix bone screw.The technique guides state that, to ensure the polyaxial head is securely attached to the bone screw, the user is to gently lift up on the placement tool and angulate the polyaxial head.In order to remove the instrument from the polyaxial head the button on the proximal end of the device can be pressed.Customer quality investigation: the following investigations were performed: broken: device condition: visual inspection performed on the returned instrument observed that the blocker portion of the device was found to be broken from the outer shaft at its welded surfaces.Both the outer and inner shafts returned were examined, and no new issues were identified.The complaint condition was able to be confirmed.Further examination showed evidence of laser welding both the distal portion of the outer shaft and the blocker.Dimensional analysis and document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed and no design issues were identified.Relevant drawings for the returned instrument were reviewed: no dimensional analysis was possible due to type of post-manufacturing damage observed where the break is located along the laser weld which joins the blocker component at the distal end of the device.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Furthermore, with the age of the device being more than 6 years, there is no indication that any manufacturing issues would have contributed to complaint condition.Conclusion: while a definitive root cause for complaint condition could not be determined from the provided information, it is likely that the age of the device and forces on the blocker laser welded on half of the outer shaft body per design drawing, could have contributed to breakage in the area of the laser weld; as such the failure mode is consistent with rough handling and device age.However, no product design issues or manufacturing discrepancies were identified during this investigation.Therefore, based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX
• 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: 7728909
• Report Number: 2939274-2018-53110
• Device Sequence Number: 16369870
• Product Code: LXH
• UDI-Device Identifier: 10705034718958
• UDI-Public: (01)10705034718958
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

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 Catalogue Number: 03.632.037
• Device Lot Number: 6678668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1