MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.0MM THREADED SPINDLE 330MM; TRACTION,APPARATUS,NON-POWERED

Model Number	394.41
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.Investigation summary background: it was reported that on (b)(6) 2019, the patient underwent an open reduction internal fixation (orif) of the distal tibia for primary fixation of a fracture.During the surgery, it was noted that the threads on the threaded spindle were stripped, so it was not allowing an unknown spindle nut to spin on the threads.The procedure was completed successfully using the other bar that was in the set.There was no surgical delay.Patient outcome was good.Concomitant devices reported: unknown spindle nut (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the 14.0 mm threaded spindle 330 mm (p/n: 394.41, lot: unk) was received showing stripped threads.Based on the exhibited damage it is likely that the part has been heavily used in the field.The returned part showed potential end of life indicator of stripped threads.Based on the laser etching on the returned spindle (without ce and lot # etch), this part was manufactured prior to se_438741 rev a (in exchange for d0003738), d0003738 rev 02, and d0003738 rev 01 (earliest available drawing in agilee system).Thus this part was manufactured prior to 01 mar 1999 and is 20+ years old.Conclusion: after a visual inspection per guidance provided, it is determined that the reusable instrument is worn from repeated use and servicing (20+ years); therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot a dhr review could not be performed as there is no lot # etch per design for the returned part.Device history batch null, device history review a dhr review could not be performed as there is no lot # etch per design for the returned part.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, the patient underwent an open reduction internal fixation (orif) of the distal tibia for primary fixation of a fracture.During the surgery, it was noted that the threads on the threaded spindle were stripped, so it was not allowing an unknown spindle nut to spin on the threads.The procedure was completed successfully using the other bar that was in the set.There was no surgical delay.Patient outcome was good.Concomitant devices reported: unknown spindle nut (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 14.0MM THREADED SPINDLE 330MM
• 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: 8833624
• Report Number: 2939274-2019-59415
• Device Sequence Number: 2742939
• Product Code: HST
• UDI-Device Identifier: 10886982199690
• UDI-Public: (01)10886982199690
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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: 394.41
• Device Catalogue Number: 394.41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 84