MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DISTRACTOR FOR 11MM ROD; TRACTION,APPARATUS,NON-POWERED

Model Number	SD393.640
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned.A review of the device history record: device history lot.Part number sd393.640.Lot number: h642864.Date of manufacture: 01-31-19.Place of manufacture: (b)(4) plant.Part expiration date: n/a (non sterile).Device history batch null, device history review the device history record(s) showed that there were no non conformances or issues during the manufacture of the product that would contribute to this complaint condition.Investigation summary background: it was reported on (b)(6) 2019, that the distractor for rod connection clamp was found out bent, upon inspection by sterile processing.There was no patient involvement.This complaint involves two (2) devices.Investigation flow: damage.Visual inspection: the distractor for 11 mm rod was received at us cq.Upon visual inspection at cq, it is observed that the threaded part of the distractor body is bent.The rest of the device and components looks good without any damage.Thus, the complaint is confirmed.Dimensional inspection: the dimensional inspection of the relevant features of the received device cannot be performed due to post manufacturing damage.Documentation/ specification review: the following drawing(s) was reviewed; distractor for 11mm rod: sd393_640 rev.D.Body assembly: sd393_640_11 rev.C.Distractor body: sd393_640_1 rev.C.Clamp: sd393_650_30 rev.A.Threaded shaft: sd393_650_20 rev.A.11 mm nut assembly adjustable clamps: 393_501 rev.J.No design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, and document specification review of the received device was performed at cq.The complaint is confirmed as the threaded part of the distractor body is bent.A definitive root cause could not be determined, it is possible that the device might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 on (b)(6) 2019, that the distractor for rod connection clamp was found out bent, upon inspection by sterile processing.There was no patient involvement.This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).

• Brand Name: DISTRACTOR FOR 11MM ROD
• Common Device Name: TRACTION,APPARATUS,NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9112539
• Report Number: 2939274-2019-60861
• Device Sequence Number: 17084198
• Product Code: HST
• UDI-Device Identifier: 10886982006608
• UDI-Public: (01)10886982006608
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/28/2019

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: SD393.640
• Device Catalogue Number: SD393.640
• Device Lot Number: H642864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/24/2019
• Patient Sequence Number: 1