MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH AWL WITH PALM HANDLE

Catalog Number 388.656

Device Problem Break (1069)

Patient Problems Fatigue (1849); Nerve Damage (1979); Paresis (1998); Weakness (2145); Injury (2348); Hypoesthesia (2352); Decreased Sensitivity (2683); No Code Available (3191); Unspecified Tissue Injury (4559)

Event Date 06/18/2014

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 (b)(6) reports an event as follows: it was reported on september 15, 2020, that the patient had an unknown surgery on an unknown date of the year of 2014.During the surgery, the instrument was broken off which ripped dura.It was unknown the surgery completed successfully.Over the time, the patient consequences was nerve damage.This complaint involves one (1) device.This report is for (1) awl with palm handle.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.D11: updated concomitant product provided for reporting.E1: initial reporter's additional information provided for reporting.H6: patient codes: additional information provided for reporting.H3, h6: investigation summary: 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.The device was discarded.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

It was reported during a lumbo sacral fusion at the level of vertebra l4-l5-s1 procedure on (b)(6) 2014, the tip of the awl broke off and caused a dural tear.A small quantity of isobetadine was injected in the intrathecal space.Post-surgery the patient shows paresis of ¿foot lifters¿ 1/5 bilateral with sensitivity issues in dermatomes l5 and s1 without radiating pain in the legs.

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.

• Brand Name: AWL WITH PALM HANDLE
• Type of Device: AWL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10600930
• MDR Text Key: 209003057
• Report Number: 8030965-2020-07504
• Device Sequence Number: 1
• Product Code: HWJ
• UDI-Device Identifier: 07611819766785
• UDI-Public: (01)07611819766785
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.656
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AWLC ÿ4 L255
• Patient Outcome(s): Required Intervention