MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRIVING CAP WITH HANDLE ADAPTER; MISC ORTHO SURGICAL INSTR EXEMPT

Catalog Number 03.010.047

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, when the set was being cleaned and decontaminated after the tibial nailing procedure, the connector was difficult to remove from the insertion handle.The threads on both items were damaged in the process of separating the devices.There was no procedure nor patient involvement.This complaint involves two (2) devices.This report is for one (1) driving cap with handle adapter.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: : part: 03.010.047; lot: 3632222; manufacturing site: (b)(4); release to warehouse date: december 13, 2010 the device history record (dhr) shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation selection investigation site: cq zuchwil selected flow(s): 2.Device interaction/functional and 3.Damaged: visual | examples: deformed/bent/cracked visual inspection: upon visual inspection of the complaint device (this article is built out of two semi-finished-parts), it can be seen that: ¿ the semi-finished-part (50158974) with the external (male) thread has some damaged thread flanks (deformation), thus confirming the complaint description.In addition, the semi-finished-part shows dents and scratches all over the part form use.¿ the semi-finished-part (50158973) with the internal (female) thread, the thread is not damaged.Furthermore, the semi-finished-part is in a good condition.Functional test: a functional test is not possible any more, based on the deformation.The reported device was assembled according to drawing, and all parts went through a 100% functional test, before they had left the production.Document/specification review: drawings and revisions are in accordance to dhr of production lot 3632222.All relevant features are defined on the used drawing revisions of dhr of production lot 3632222.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no document/specification review is needed.Dimensional inspection: the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the damage.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Summary: there is no particular information on what happened to this article by the customer; unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary for worn or damaged instruments to be replaced and/or to be operated according to the technique guide.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

The threads of the connector were damaged in the process of separating the devices.

• Brand Name: DRIVING CAP WITH HANDLE ADAPTER
• Type of Device: MISC ORTHO SURGICAL INSTR EXEMPT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8243079
• MDR Text Key: 132924434
• Report Number: 8030965-2019-59819
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819760844
• UDI-Public: (01)07611819760844
• 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
• Report Date: 12/17/2018

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
• Device Catalogue Number: 03.010.047
• Device Lot Number: 3632222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/13/2019
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 01/31/2019
• Patient Sequence Number: 1