MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; WIRE,SURGICAL

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown guide/compression/k-wires /unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2018, that the patient had the device implant procedure about 8 years ago.The patient underwent planned hardware removal surgery on (b)(6) 2018 with h-tep at coxarthroses.During the implant removal procedure, the helical blade fell apart and could not be removed.The removal surgery on (b)(6) 2018 was interrupted without success after 1.5 hours.Further surgery to remove the blade was performed on (b)(6) 2018 and was completed successfully.The implant removal for the damaged blade took forty-five (45) minutes.There was a twenty (20) minute surgical delay.Concomitant devices reported: pfna, length 240mm (product code: 272.261s, lot #: 2465337, quantity: 1); pfna end caps (product code: 273.155s, lot #: 2461996, quantity: 1).This report is for one (1) unknown - guide/compression/k-wires.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Product investigation was completed.The visual inspection has shown that a unknown k-wire together with an hook are jammed inside the pfna blade.The visual inspection has shown that a unknown k-wire together with an hook are jammed inside the pfna blade.As the article and lot number is unknown, the device history record and the manufacturing documents could not be reviewed.It can be assumed that this complaint condition is most likely due to a complication during operation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected 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 Description

Device report from synthes europe reports an event in germany as follows: it was reported that a patient was implanted with a hardware approximately eight (8) years ago.The patient underwent planned hardware removal surgery on (b)(6) 2018 with h-tep at coxarthrose.During implant removal procedure, the helical blade fell apart and could not be removed.The removal surgery on (b)(6) 2018 was interrupted without success after 1.5 hours.Further surgery to remove the blade was performed on (b)(6) 2018 and was completed successfully.The implant removal for damaged blade took 45 minutes.There was 20 minutes surgical delay.After hardware removal, h-tep was implanted as planned.Upon receiving the devices at the manufacturer, during preliminary inspection on (b)(6)2018, it was noted that the hook for removal of pfna blade and k wire were jammed in pfna blade.This (b)(4) capture the hook of pfna blade, pfna blade, and an unknown k-wires that were jammed in pfna blade as per manufacturer's preliminary inspection.(b)(4) captures intra-operative event of broken devices.This report is for one (1) unknown k-wire this is report 3 of 3 for (b)(4).

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.The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.Potential date of event is (b)(6) 2018.Exact date is unknown.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.

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.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.

• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8260515
• MDR Text Key: 133836946
• Report Number: 8030965-2019-60040
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/19/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: 01/30/2019; 01/31/2019; 02/19/2019
• Supplement Dates FDA Received: 01/30/2019; 01/31/2019; 02/28/2019
• Patient Sequence Number: 1
• Patient Age: 70 YR