MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFRAME RETRACTOR HOLDER- ADJUSTABLE; MISC ORTHO SURGICAL INSTR

Model Number	387.361
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part: 387.361; lot: l882571; manufacturing site: (b)(4); release to warehouse date: may 15, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the synframe guide rod was received at the us customer quality (cq).The device had some scratches on it.The device appeared to be stuck in an articulated position and could not be returned to a neutral one.The lock for the attachment subcomponent, the locking device subcomponent, could be seen in the engaged position.The internal spring of the device could be seen inside the device, but its condition could not be verified.No other issues could be identified with the returned portions of the device.Functional test: a functional test was performed on the synframe guide rod.The pusher subcomponent was able to move up and down loosely, remaining in the down position unless pulled up.The slider subcomponent was able to switch from the locked to unlocked position and back only when the pusher subcomponent was manually held up.Regardless of the position of the pusher, the locking device subcomponent was stuck in the engaged position, preventing the attachment subcomponent from articulating about the dowel pin subcomponent.The complaint condition can be replicated with the returned device(s).Dimensional inspection: a dimensional inspection was not performed due to a lack of access to the relevant features.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Synframe guide rod w/adjust-clamp w/snap.Manufacturing record evaluation: the received device was manufactured at the (b)(4) site on may 15, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint was confirmed for the synframe guide rod.In addition to having surface scratches, the device had seized in an articulated position.The locking device subcomponent was stuck in the engaged position, and the pusher subcomponent was not functioning as intended.The pusher, when pressed down, should disengage the locking device, but in this case the pusher button was freely moving up and down without affecting the locking device.As a result, the attachment subcomponent could not rotate.The device was unable to be disassembled in order to inspect the condition of the internal parts.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.No definitive root cause could be determined, but it is possible that the pusher and/or the locking device subcomponents were damaged.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 during a routine inspection of the central sterile processing department on (b)(6) 2019, a synframe retraction holder-adjustable was stuck and the arm would not articulate.When pushing the button on the instrument, it will not move, and it should.There was no patient involvement.This report is for a synframe retractor holder- adjustable.This is report 1 of 1 for (b)(4).

• Brand Name: SYNFRAME RETRACTOR HOLDER- ADJUSTABLE
• 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: 8887520
• Report Number: 2939274-2019-59756
• Device Sequence Number: 19657019
• Product Code: LXH
• UDI-Device Identifier: 10705034771175
• UDI-Public: (01)10705034771175
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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: 387.361
• Device Catalogue Number: 387.361
• Device Lot Number: L882571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1