MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM CANNULATED SCREW 32MM THREAD 80MM; SCREW,FIXATION,BONE

Model Number	209.880
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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) 2020, during an unknown procedure, the cannulated screw pulled through the washer.Three washers were used with one failure.It is unknown if the procedure was completed successfully.It is unknown if there was a surgical delay.Patient outcome was unknown.Concomitant devices reported: cannulated screw (part# 209.990, lot# unknown, quantity 1).Cannulated screw (part# 209.945, lot# unknown, quantity 1).Washer (part# 219.99, lot# unknown, quantity 2).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent a hardware removal as the cannulated screw pulled through the washer as evident in the preoperative films.Three cannulated screws and washers were removed.The surgeon removed the cannulated screws so that a spine surgeon could perform a multi level lumbar/sacral fusion.Concomitant devices reported: cannulated screw (part# 208.442, lot# 9921917, quantity 1), unknown cannulated screw (part# unknown, lot# unknown, quantity 1), washer (part# 219.99, lot# 2l68359, quantity 1), washer (part# 219.99, lot# 2l95943, quantity 1).
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.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.
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.H3, h4, h6- the 6.5mm cannulated screw 32mm thread 80mm (p/n: 208.438, lot number: h547583) was received at us cq.Upon visual inspection, the internal threads of the screw head are stripped, and there are cosmetic scratches along the shaft that would not contribute to the complaint condition but are perhaps caused as a result of the condition.The returned photo does not affect the investigation.This complaint is not confirmed as the complaint condition cannot be replicated.However, the internal threads of the screw head are stripped, and the screw shaft is scratched/nicked.No definitive root cause could be determined based on the provided information.It is possible that the screw was tightened with excessive force, causing the stripped condition.No new, unique or different patient harms were identified as a result of this evaluation.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.Device history lot manufacturing location: monument, manufacturing date: 17-jan-2018, part number: 208.438, 6.5mm cannulated screw 32mm thread 80mm, lot number: h547583 (non-sterile).This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that 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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.G4: the incorrect g4 date was inadvertently utilized in initial medwatch.The correct date is may 4, 2020.  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: 6.5MM CANNULATED SCREW 32MM THREAD 80MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10080489
• Report Number: 2939274-2020-02485
• Device Sequence Number: 3792128
• Product Code: HWC
• UDI-Device Identifier: 10886982151216
• UDI-Public: (01)10886982151216
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K021932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/04/2020

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: 209.880
• Device Catalogue Number: 208.438
• Device Lot Number: H547583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/26/2020; 06/30/2020; 07/02/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 06/17/2020; 07/01/2020; 07/02/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7.3MM CANNULATED SCREW 32MM THREAD/100MM; 7.3MM CANNULATED SCREW 32MM THREAD/145MM; WASHER 13.0MM; WASHER 13.0MM; WASHER 13.0MM
• Patient Age: 30 YR